Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.07.2019 – 30.09.2019

Опубліковано 08.10.2019 о 16:03

Великобританія

https://www.gov.uk/drugdevicealerts?keywords=&alert_type[]=devices&issued_date[from]=&issued_date[to]=

 

  1. Kiwi Complete Vacuum Delivery System – risk of failure to achieve or maintain vacuum during use (specific lot affected) (MDA2019/031)

Manufactured by Clinical Innovations – if the device fails to generate or maintain a vacuum during the assisted delivery of a baby, additional intervention will be needed.

  • Alert type: Medical device alert

 Medical specialism: Obstetrics and gynaecology

 Issued: 30 September 2019

  1. All models of T34 ambulatory syringe pumps – updated cleaning advice and maintenance requirements due to the risk of fluid ingress (MDA/2019/030)

Manufactured by CME (a BD company) – function may be affected by fluid getting into the pump and building up over time because of specific cleaning and disinfection practices.

  • Alert type: Medical device alert

 Medical specialism: Care home staff and 3 others

 Issued: 18 September 2019

  1. Deltec Gripper non-coring needles and PORT-A-CATH trays containing Gripper needles – recall due to risk of needle occlusion

Manufactured by Smiths Medical: due to a manufacturing process failure, needles may be occluded, potentially causing a delay to treatment.

  • Alert type: Medical device alert

 Medical specialism: Anaesthetics and 13 others

 Issued: 12 September 2019

  1. Microneedling pens: Dermapen 3 and Dermapen Cryo Sterile single use needle cartridge tips for: Dermapen 3 – risk of injury or infection (MDA/2019/028)

Manufactured by Equipmed and other trading names (listed in the ‘Manufacturer contacts’ section), distributed in the UK by Naturastudios.

  • Alert type: Medical device alert

 Medical specialism: Cosmetic surgery and 1 others

 Issued: 27 August 2019

  1. Automated external defibrillators: All Telefunken HR1 & FA1 – no valid CE certificate (MDA/2019/027)

Manufactured by Defiteq International BV or GGT Holding BV – the safety and performance of these devices cannot be verified and their safe use can no longer be assured.

  • Alert type: Medical device alert

 Medical specialism: Anaesthetics and 21 others

 Issued: 25 July 2019

Professional use capillary blood specimen collection: BD Microtainer® tubes – risk of blood leakage and/or incorrect test results due to defective tubes

Manufactured by Becton Dickinson (BD) – tubes may contain a hole or be damaged or deformed, potentially causing blood leakage and/or an inadequate blood-to-additive ratio leading to incorrect test results.

  • Alert type: Medical device alert

 Medical specialism: Anaesthetics and 13 others

 Issued: 24 July 2019

  1. IntelliVue MX40 patient-worn monitors – increased power consumption and no visual or audible alarms when batteries are low (MDA/2019/025)

Manufactured by Philips – devices may lose power earlier than expected and users may not realise the loss of monitoring due to no alarm, which could contribute to a delay in emergency treatment.

  • Alert type: Medical device alert

 Medical specialism: Anaesthetics and 6 others

 Issued: 2 July 2019

 

Франція

https://ansm.sante.fr/Sinformer/InformationsdesecuriteAutresmesuresdesecurite

 

30/09/2019 – Radiothérapie (logiciel) – Mosaiq® – Elekta – Information de sécurité

30/09/2019 – Appareil de radiologie fixe – RX- DR 800. – Agfa HealthCare N.V. – Information de sécurité

30/09/2019 – Echographe ultrason ILab™ Polaris Multi-Modality Guidance System – Boston Scientific Corporation – Information de sécurité

27/09/2019 – Alerte – LAP : Logiciel aide à la prescription Diane Réa – Bow Médical – Information de sécurité

26/09/2019 – Système régulation température corporelle – Micro-Temp, Gentherm Medical, LLC – Information de sécurité

24/09/2019 – Alerte – Dispositifs CERAM CONCEPT en dépôt dans les établissements de santé – Information de sécurité

19/09/2019 – Système régulation température corporelle – Blanketrol III, Système d’hyper-hypothermie – Genthermcompany / Gamida – Information de sécurité

19/09/2019 – Logiciel (divers) – CHA Anesthesia & CHA Critical Care – GE Healthcare – Information de sécurité

19/09/2019 – Alerte – Moniteur de surveillance cardio-respiratoire – Life Scope G5 et Life Scope G7 – Nihon Kohden Corporation – Information de sécurité

18/09/2019 – Alerte – Système de traitement d’images numériques – RadiForce, Eizo Corporation – Information de sécurité

17/09/2019 – Alerte – Lève-personne mobile -Samsoft 175 et Mini-Samsoft 150 – Drive Devilbiss Healthcare France – Information de sécurité

17/09/2019 – Ventilateur d’anesthésie – Aespire 7100/100/Protiva/Carestation, Aestiva 7900/MRI/7100 – GE Healthcare – Information de sécurité

17/09/2019 – Alerte – Orthopédie – Agrafes, plaques et vis d’ostéosynthèse- Tornier – Information de sécurité

17/09/2019 – Appareil de radiologie RX- FDR Go – Shimadzu Corporation, Medical Systems Division – Information de sécurité

17/09/2019 – Alerte – Thérapie par pression négative – Venturi Compact – Talley Medical – Information de sécurité

16/09/2019 – ORL – Instruments chirurgicaux réutilisables Panetti Saug-Rundschnittmesser – Spiggle & Theis Medizintechnik GmbH – Information de sécurité

13/09/2019 – Alerte – Chirurgie assistée par ordinateur – Rosa Brain 3.0 – MedTech – Zimmer Biomet – Information de sécurité

12/09/2019 – Pousse-seringue ambulatoire T34 – Caesarea Medical Electronics Ltd /BD – Information de sécurité

11/09/2019 – Alerte – Tables radiantes – Giraffe et Panda iRes – GE Healthcare – Information de sécurité

10/09/2019 – Alerte – Désinfectant pour STE/Endoscopie – Bandelettes Phago’Scope APA – Christeyns France – Information de sécurité

09/09/2019 – Prothèse totale de hanche (orthopédie) – Tête fémorale 28 mm avec offset de -3.5 (msfmh/CC28-3.5) – Stanmore Implants – Information de sécurité

09/09/2019 – Alerte – Fauteuil de soins – EPD Package 2 – Pivotal Health Solutions – Information de sécurité

09/09/2019 – Alerte – Moteur pour système de CEC – CentriMag Motor, OUS – Abbott Medical – Information de sécurité

06/09/2019 – Alerte – Moniteurs (Bis – EEG) BIS™ Vista and BIS™ View Monitoring Systems – Covidien/Medtronic – Information de sécurité

06/09/2019 – Alerte – Générateur thermique de Cec-Heater Unit HU35 – Getinge Maquet- Information de sécurité

30/08/2019 – Alerte – Prothèse totale de hanche – Tiges fémorales sans ciment (Modulus, Modulus-R et Revision) et tiges fémorales cimentées (Revision LR) – Lima Corporate – Information de sécurité

28/08/2019 – Alerte – Biopsie – Aiguille de ponction – Fetal Blood Sampling Kit – Rocket Medical – Information de sécurité

28/08/2019 – Alerte – Moniteur d’hémodialyse PrisMax, V2, Row – Baxter Healthcare SA – Information de sécurité

27/08/2019 – Pansement / soin (autre) – Adaptic™ Non-Adhering Dressing (7.6cm x 7.6cm), Systagenix Wound Management Ltd. – Information de sécurité

27/08/2019 – Stérilisateur – Steam sterilizer, Getinge Sterilization AB – Information de sécurité

26/08/2019 – Alerte – Circuit ou pack pour CEC – Oxygénateur Trilly Pediatric – Eurosets SRL – Information de sécurité

26/08/2019 – Alerte – Défibrillateurs cardiaques implantables sous-cutanés (S-ICD) A209 Emblem et A219 Emblem MRI S-ICD – Société Boston Scientific – Information de sécurité

26/08/2019 – Alerte – Chariot à douches – Concerto / Basic Shower Trolley – Arjo Huntleigh AB – Information de sécurité

23/08/2019 – Alerte – Sonde vésicale – KCH drain de vessie foetale, Rocket® – Information de sécurité

21/08/2019 – Alerte – Aides aux soins et à la mobilité – Chariots pour pèse-bébés Seca 402 et Seca 403 – Seca – Information de sécurité

21/08/2019 – Alerte – Accessoire – IRM- Endorectal Coils- Rapid Biomedical – Information de sécurité

20/08/2019 – Alerte – Masque d’anesthésie – Economy, Anaesthetic Face Masks, Sizes 3, 4, 5 and 6, Adult, 22F, Intersurgical Ltd – Information de sécurité

20/08/2019 – Alerte – Stimulateurs cardiaques implantables Micra – Medtronic – Information de sécurité

13/08/2019 – Alerte – Appareil de radiologie interventionnelle – RX- Philips Azurion with software version 1.2, Philips Medical Systems Nederland B.V.- Information de sécurité

13/08/2019 – Alerte – ECG- Electrocardiographe Philips PageWriter TC Cardiographs (TC20/30/50/70) Philips Medical Systems – Information de sécurité

13/08/2019 – Alerte – Incubateur néonatal – Giraffe OmniBedTM Carestation – GE Medical Systems – Information de sécurité

13/08/2019 – Alerte – Appareil radiologie interventionnelle-RX- Philips Azurion system with software version 1.2 (démarrage à froid de l’équipement )- Philips Medical Systems Neder – Information de sécurité

13/08/2019 – Alerte – Dispositif de cryothérapie – Cooltechnology – High Technololy Products SL – Information de sécurité

09/08/2019 – Alerte – Electrodes – Fils conducteurs pour électrodes à cupule Gold et à bouton pression utilisés pour tester les potentiels évoqués auditifs, neurologiques ou vestibulaires – Otometrics – Rappel

08/08/2019 – Alerte – Appareil de radiologie interventionnelle – RX- Artis Zee/ Artis Q/Q.Zen – Siemens Healthcare GmbH – Information de sécurité

07/08/2019 – Mammographe – Mammomat Revelation – Siemens Healthcare – Information de sécurité

06/08/2019 – Alerte – Scanner – RX- Ingenuity CT ; Ingenuity Core 128 ; Ingenuity Core ; iCT ; iCT SP ; Brilliance 64 ; IQon Spectral CT ; Ingenuity TF PET/CT ; Vereos PET/CT – Philips Medical Systems – Information de sécurité

05/08/2019 – Alerte – Ecg ( Electrocardiographe ) – Systèmes Mac VU360, GE Medical Systems Information Technologies – Information de sécurité

05/08/2019 – Alerte – Pompe à insuline externe – Dexcom G4 Platinum, Dexcom G5 Mobile – Dexcom Inc – Information de sécurité

05/08/2019 – Alerte – Housse de protection – Protections de sonde peropératoire – Microtek Medical Limited – Ecolab – Rappel

05/08/2019 – Générateur de radiofréquence – Système d’ablation cardiaque Maestro 4000 – Boston Scientific Corporation – Information de sécurité

02/08/2019 – Exploration fonctionnelle respiratoire – FeNO+ – Medisoft – Information de sécurité

01/08/2019 – Alerte – Scanner – RX- Somatom go.Up, Somatom go.TOP, Somatom go.ALL – Siemens Healthcare GmbH – Information de sécurité

31/07/2019 – Alerte – Ventilateur transport et urgence – Monnal T60 – Air Liquide Medical Systems – Information de sécurité

31/07/2019 – Alerte – Logiciel (divers) – Mako – Mako Surgical Corporation – Information de sécurité

31/07/2019 – Alerte – Ventilateur (réanimation, transport et usage à domicileE) – Monnal T50, T50 DE et T50 JP, Monnal T75, T75 JP et T75 CO2, Monnal T60 et T60 JP,et Monnal T40 et T40 DE – Air liquide Medical Systems – Information de sécurité

31/07/2019 – Chirurgie assistée par ordinateur – Da Vinci Xi et Da vinci X – Intuitive Surgical – Information de sécurité

31/07/2019 – Mobile de radiologie – Système Fluorostar 7900 – GE Healthcare – Information de sécurité

30/07/2019 – Alerte – Laser (ophtalmologie) – Laser photocoagulateur Easyret – Quantel Medical – Information de sécurité

30/07/2019 – Appareil automatise de massage cardiaque – Lucas 2 Chest Compression System – Jolife AB Physio-Contrôle – Information de sécurité

30/07/2019 – Alerte – Ecg (Electrocardiographie) – Ecg Eolys – Information de sécurité

30/07/2019 – Alerte – Système d’abblation thermique bronchique – InterVapor – Uptake Medical Technology, Inc – Information de sécurité

29/07/2019 – ORL – Cartilage Microtome System – Grace Medical, Inc – Information de sécurité

26/07/2019 – Alerte – LAP : Logiciel Aide à la Prescription Osiris – ETCCS – Information de sécurité

25/07/2019 – Alerte – Contre-pulsion intra-aortique / CPBIA Datascope – Cardiosave Hybrid CPBIA, Cardiosave Rescue CPBIA, CS100, CPBIA, CS300 CPBIA – Datascope Corp – Information de sécurité

25/07/2019 – Alerte – Défibrillateur externe HeartStart MRx Defibrillator/Monitor – Philips Medical Systems – Information de sécurité

24/07/2019 – Médecine nucléaire – Gamma caméra BrightView, BrightView X, BrightView XCT – Philips – Information de sécurité

24/07/2019 – Echographe ultrason – Appareils WS80A, HS70A – Samsung – Information de sécurité

24/07/2019 – Alerte – Défibrillateur (accessoires) – Electrodes de défibrillation GS corPatch easy pre-connected – Leonhard Lang GmbH – Information de sécurité

23/07/2019 – Radiothérapie – Logiciel iGuide – HexaPOD evo RT System – Elekta – Information de sécurité

22/07/2019 – Anesthésie péridurale (set) – Perifix® Catheter Connector – B Braun – Information de sécurité

19/07/2019 – Alerte – Générateur à ultrasons pour thrombolyse – Ekos Control System 4.0 – Ekos Corporation – Information de sécurité

16/07/2019 – TEP PET – Scan médecine nucléaire – Vereos PET/TDM – Philips – Information de sécurité

16/07/2019 – Echographe ultrason (sonde) – RIC5-9-D, RIC5-9A-RS – GE Healthcare – Information de sécurité

16/07/2019 – Alerte – Cathéter artériel – Kit de Cathétérisme Artériel – Téléflex Medical Europe LTD (Arrow International) – Information de sécurité

12/07/2019 – Alerte – Ballon intra-gastrique End-ball – Laboratoire Endalis – Information de sécurité

12/07/2019 – Défibrillateur externe Meducore Standard 2 – Weinmann – Information de sécurité

11/07/2019 – Alerte – Microscope opératoire HS Hi-R NEO 900 avec les statifs de sol FS 2-21, FS 2-25 and FS 3-45 – Möller Wedel GMBH – Information de sécurité

10/07/2019 – Alerte – Cardiologie – Systèmes de perfusion Quantum® – Spectrum Medical Ltd – Information de sécurité

09/07/2019 – Système de planification de traitement (TPS) – Radiothérapie – Monaco RTP System – Elekta – Information de sécurité

09/07/2019 – Alerte – Pompe à insuline externe – Medtronic MiniMed Paradigm, Infusion Pumps – Medtronic MiniMed Paradigm VEO – Information de sécurité

08/07/2019 – Valve biologique percutanée aortique Edwards Centera™ Transcatheter Heart Valve System – Edwards Lifesciences – Information de sécurité

08/07/2019 – Alerte – Circuit ou pack pour ECMO – Deltastream DP3 Pumphead, Xenios AG – Fresenius Medical Care France – Information de sécurité

08/07/2019 – Endoscope (accessoire) – Bras du panneau de commande MAJ-1664 utilisé avec la desserte WM-NP2 ou WM-DP2 – Olympus – Information de sécurité

04/07/2019 – Alerte – Appareil de radiologie interventionnelle – RX – OrthoScan Mini C-Arm X-Ray System – OrthoScan Inc. – Information de sécurité

04/07/2019 – Alerte – Dispositif de transport ou conservation d’organes – Biotainer – Alcis – Information de sécurité

03/07/2019 – Alerte – Champ opératoire Absorbent cotton O.R, Medline International France SAS – Information de sécurité

03/07/2019 – Alerte – Ventilateur de réanimation- Evita Infinity V500, Babylog VN500 et Evita V300 – Dräger Medical – Information de sécurité

03/07/2019 – Alerte – Système régulation température corporelle- Tecotherm NEO, Tec Com Gmbh – Information de sécurité

03/07/2019 – Alerte – ECG (electrocardiographe) – Holter System – Edan Instruments Inc – Information de sécurité

02/07/2019 – Circuit de ventilation patient – Circuit respiratoire Flextube chauffé 15mm – Intersurgical Ltd – Information de sécurité

 

 

Німеччина

 

https://www.bfarm.de/SiteGlobals/Forms/Suche/EN/kundeninfo_Filtersuche_Formular_en.html;jsessionid=46FB614DB55781B0D8C828DD18B3BCAD.2_cid344?resourceId=4527732&input_=4527724&pageLocale=en&oneOfTheseWords=&submit=filter

 

  • 09.30

Urgent Field Safety Notice for Alinity hq Analyzer and Alinity hs Slide Maker Stainer Module by Abbott International RA Vigilance Team

In-vitro diagnostics – haematological, histological and cytological products

PDF141KB

  • 09.30

Urgent Field Safety Notice for DYNACIDE PA by Christeyns FRANCE

General equipment for medical treatment – cleaning / disinfection / sterilisation

PDF1MB

  • 09.30

Urgent Field Safety Notice for Atellica UAS 800 analyzer by Siemens Healthcare Diagnostics Inc. Tarrytown

In-vitro diagnostics – equipment / products for clinical chemistry

PDF58KB

  • 09.30

Urgent Field Safety Notice for Substrate Buffer (SUB-D) by Hain Lifescience GmbH

In-vitro diagnostics – microbiological products

PDF134KB

  • 09.30

Urgent Field Safety Notice for Alinity i S.A. Myoglobin Reagent Kit by Abbott Ireland Diagnostics Division

In-vitro diagnostics – immunological products

PDF154KB

  • 09.30

Urgent Field Safety Notice for HemoCue Glucose 201 DM RT Analyzer by HemoCue AB

In-vitro diagnostics – equipment / products for clinical chemistry

PDF1MB

  • 09.30

Urgent Field Safety Notice for Charder _ MHS2510-MHS2510I by Charder Electronic Co., Ltd.

General equipment for medical treatment – ward equipment and equipment for emergency medical services

PDF204KB

  • 09.30

Urgent Field Safety Notice for Multilevel Saliva Calibrator Set and Cortisol Cortison Control Level I and II by Chromsystems Instruments & Chemicals GmbH

In-vitro diagnostics – equipment / products for clinical chemistry

PDF2MB

  • 09.30

Urgent Field Safety Notice for Enzymatisches Kreatinin, Triglyceride-GPO, Harnsäure, Direktbilirubin, Gesamtbilirubin by Beckman Coulter, Inc.

In-vitro diagnostics – equipment / products for clinical chemistry

PDF87KB

  • 09.27

Urgent Field Safety Notice for N Antiserum to Human Albumin by Siemens Healthcare Diagnostics Products GmbH

In-vitro diagnostics – immunological products

PDF704KB

  • 09.27

Urgent Field Safety Notice for S4C OCCIPITAL PLATE SMALL 5 HOLES by Aesculap AG

Non-active implants – bone surgery

PDF258KB

  • 09.27

Urgent Field Safety Notice for IH-1000 Analyzer by Bio-Rad Laboratories, DiaMed GmbH

In-vitro diagnostics – haematological, histological and cytological products

PDF4MB

  • 09.27

Urgent Field Safety Notice for MYO2 (Tina-quant Myoglobin Gen.2) by Roche Diagnostics GmbH

In-vitro diagnostics – immunological products

PDF300KB

  • 09.27

Urgent Field Safety Notice for ALB2 (Albumin Gen.2), BILT3 (Bilirubin Total Gen.3) by Roche Diagnostics GmbH

In-vitro diagnostics – equipment / products for clinical chemistry

PDF386KB

  • 09.27

Urgent Field Safety Notice for IGG-2 by Roche Diagnostics GmbH

In-vitro diagnostics – immunological products

PDF536KB

  • 09.27

Urgent Field Safety Notice for Adult/Small Adult Venous Hardshell Cardiotomy Reservoir (VHK) and combination of reservoir with oxygenator (VKMO(D)) by Maquet Cardiopulmonary GmbH

Surgical equipment/ Anaesthesia – surgical equipment

PDF3MB

  • 09.27

Urgent Field Safety Notice for Various Biomet Products by Biomet Orthopedics, LLC

Non-active implants – bone surgery

PDF234KB

  • 09.27

Urgent Field Safety Notice for MOSAIQ by IMPAC Medical Systems, Inc.

Radiotherapy / Radiation protection – radiotherapy treatment planning systems

PDF57KB

  • 09.27

Urgent Field Safety Notice for SOMATOM CT scanner, several types by Siemens Healthcare GmbH Computed Tomography (CT)

Radiological technology – CT scanners

PDF6MB

  • 09.26

Urgent Field Safety Notice for MONOPLUS VIOLET 0(3,5)150CM HR48 LOOP(M) DDP by B. Braun Surgical S.A.

Dressings / Pads – surgical sutures, vascular loops etc.

PDF730KB

  • 09.26

Urgent Field Safety Notice for EO-150 Ventilator by EOVE

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF176KB

  • 09.25

Urgent Field Safety Notice for Heater Unit HU35 by Maquet Cardiopulmonary AG

Surgical equipment/ Anaesthesia – surgical equipment

PDF3MB

  • 09.25

Urgent Field Safety Notice for Chartr EP 200 by Natus Medical Denmark going on the market under GN Otometrics A/S brand name

Medical electronics / Electromedical devices – ENT equipment

PDF257KB

  • 09.25

Urgent Field Safety Notice for Embryology Heated Plate within the RI Witness by Cooper Surgical Inc.

In vitro fertilization – others

PDF255KB

  • 09.24

Urgent Field Safety Notice for Dario-Blood Glucose Tracker (Android Application) by LabStyle Innovations, Ltd

Medical electronics / Electromedical devices – electric blood glucose meters

PDF138KB

  • 09.24

Urgent Field Safety Notice for GCS by PAJUNK GmbH Medizintechnologie

Medical instruments for use in humans – general instruments

PDF858KB

  • 09.23

Urgent Field Safety Notice for MSI Biopsieinstrument by adeor Medical AG Unterhaching

Medical instruments for use in humans – general instruments

PDF127KB

  • 09.23

Urgent Field Safety Notice for iLab Polaris Multi-Modality Guidance System by Boston Scientific Corporation Marlborough

Ultrasonics – ultrasonic diagnostic equipment

PDF517KB

  • 09.23

Urgent Field Safety Notice for Adapta, Versa, Sensia, Relia, Attesta, Sphera, and Vitatron A, E, G, Q series Implantable Pulse Generators (IPG) by Medtronic Inc

Active implantable medical devices – cardiac pacemakers

PDF741KB

  • 09.20

Urgent Field Safety Notice for Patientenkabel, D by Medset Medizintechnik GmbH

Medical electronics / Electromedical devices – electrodiagnostics

PDF746KB

  • 09.20

Urgent Field Safety Notice for Rusch TracFlex Plus Phonation Set, Cuffed; Rusch TracFlex Plus Set, cuffed; TracFlex Plus PDT Set; Ruschcare TracFlex Plus Phonation Set, Cuffed by Teleflex (Perak West Malaysia)

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF154KB

  • 09.19

Urgent Field Safety Notice for DispoGrip by Teleflex Medical USA

Optics / Precision engineering – medical microscopes (does not incude laboratory microscopes)

PDF193KB

  • 09.19

Urgent Field Safety Notice for EYEJET CTR by Morcher GmbH

Non-active implants – special implants

PDF3MB

  • 09.19

Urgent Field Safety Notice for INNOTERE Paste-CPC, 3ml by InnoTERE GmbH

Non-active implants – materials for implants

PDF2MB

  • 09.19

Urgent Field Safety Notice for BVM RESUSCITATOR ADULT 1.5L BAG SIZE 3 & 5 MASK by Intersurgical Ltd.

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF305KB

  • 09.19

Urgent Field Safety Notice for RT-PLUS MODULAR FEMORAL BLOCK by Smith & Nephew Orthopaedics AG

Non-active implants – bone surgery

PDF318KB

  • 09.18

Urgent Field Safety Notice for Zenith Branch Endovascular Graft Iliac Bifurcation by William A Cook Australia Pty Ltd

Non-active implants – special implants

PDF273KB

  • 09.18

Urgent Field Safety Notice for Medline Sterile Absorbent Cotton O.R Towels by ArcRoyal Ltd.

Surgical equipment/ Anaesthesia – surgical equipment

PDF1MB

  • 09.18

Urgent Field Safety Notice for Warming Solution Set 205, Warming Kit 102, Vitrification Solution Set 110, Vitrification Kit 101 by REPROLIFE

In vitro fertilization – others

PDF627KB

  • 09.17

Urgent Field Safety Notice for Efficia DFM100 by Philips Goldway (Shenzhen) Industrial Inc.

Medical electronics / Electromedical devices – electrotherapy

PDF2MB

  • 09.17

Urgent Field Safety Notice for Steril verpackte Sets mit Trägerschalen (Nierenschalen, Instrumentablett aus Faserformmaterial: Pappe) by Lohmann und Rauscher GmbH & Co. KG

Dressings / Pads – others

PDF16KB

  • 09.17

Urgent Field Safety Notice for Easyret by QUANTEL M EDICAL

ophthalmological technology – equipment for ophthalmological therapeutics

PDF854KB

  • 09.16

Urgent Field Safety Notice for Ru-106 Augenapplikatoren by Eckert & Ziegler BEBIG GmbH

Radiotherapy / Radiation protection – nuclear medical therapeutic equipment

PDF2MB

  • 09.16

Urgent Field Safety Notice for Aquilex Fluid Control System by W.O.M. World of Medicine AG

Surgical equipment/ Anaesthesia – surgical equipment

PDF128KB

  • 09.13

Urgent Field Safety Notice for Economy, Anaesthetic Face Masks, Sizes 3, 4, 5 and 6, Adult, by Intersurgical Ltd.

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF310KB

  • 09.13

Urgent Field Safety Notice for Medsil Intragastric Balloon by Medsil

Non-active implants – special implants

PDF265KB

  • 09.12

Urgent Field Safety Notice for 1-DAY ACUVUE MOIST for ASTIGMATISM by Johnson & Johnson Vision Care

ophthalmological technology – contact lenses

PDF229KB

  • 09.12

Urgent Field Safety Notice for DR 800 by Agfa HealthCare N.V.

Radiological technology – stationary radiological equipment

PDF121KB

  • 09.12

Urgent Field Safety Notice for TxRx Knee Coil/Quality Electrodynamics by Quality Electrodynamics, LLC (QED)

Electromedical fields – equipment for MR tomography

PDF464KB

  • 09.12

Urgent Field Safety Notice for Euphora and Solarice Rapid Exchange Balloon Dilatation Cathete by Medtronic Inc

Injections / Infusions / Transfusions / Dialysis – catheters

PDF175KB

  • 09.12

Urgent Field Safety Notice for MAJ-209 SINGLE USE SUCTION VALVE by Olympus Medical Systems Corp.

Optics / Precision engineering – endoscopes

PDF454KB

  • 09.10

Urgent Field Safety Notice for RiaRSR AChRAb by RSR Limited

In-vitro diagnostics – immunological products

PDF2MB

  • 09.10

Urgent Field Safety Notice for Leadless pacemaker Micra by Medtronic Inc

Active implantable medical devices – cardiac pacemakers

PDF94KB

  • 09.10

Urgent Field Safety Notice for NeoDura Dural Repair Patch by Medprin Biotech GmbH

Non-active implants – special implants

PDF142KB

  • 09.06

Urgent Field Safety Notice for CRP FS by DiaSys Diagnostic Systems GmbH

In-vitro diagnostics – immunological products

PDF241KB

  • 09.06

Urgent Field Safety Notice for FDR Go by Shimadzu Corporation

Radiological technology – stationary radiological equipment

PDF54KB

  • 09.06

Urgent Field Safety Notice for STFR – Tina-quant Soluble Transferrin Receptor by Roche Diagnostics GmbH

In-vitro diagnostics – immunological products

PDF679KB

  • 09.06

Urgent Field Safety Notice for Infusionsgerät by Angiokard Medizintechnik GmbH

Injections / Infusions / Transfusions / Dialysis – infusion kits

PDF26KB

  • 09.06

Urgent Field Safety Notice for T34 syringe pump by Caesarea Medical Electronics Ltd.

Injections / Infusions / Transfusions / Dialysis – infusion technology

PDF806KB

  • 09.06

Urgent Field Safety Notice for Atellica UAS 800 analyzer by Siemens Healthcare Diagnostics Inc. Tarrytown

In-vitro diagnostics – equipment / products for clinical chemistry

PDF64KB

  • 09.06

Urgent Field Safety Notice for KAPPA (EP171) RABBIT MONOCLONAL PRIMARY ANTIBODY by Cell Marque Corporation

In-vitro diagnostics – haematological, histological and cytological products

PDF55KB

  • 09.06

Urgent Field Safety Notice for Atellica IM 1300 and IM 1600 Analyzers by Siemens Healthcare Diagnostics Inc. Tarrytown

In-vitro diagnostics – equipment / products for clinical chemistry

PDF87KB

  • 09.06

Urgent Field Safety Notice for ORGENTEC ANAscreen Alegria by Orgentec Diagnostika GmbH

In-vitro diagnostics – immunological products

PDF930KB

  • 09.06

Urgent Field Safety Notice for C3 CryoSonde by Inomed Medizintechnik GmbH, Emmendingen

Surgical equipment/ Anaesthesia – surgical equipment

PDF4MB

  • 09.05

Urgent Field Safety Notice for Meche de Gaze by Lohmann und Rauscher GmbH & Co. KG

Dressings / Pads – dressings

PDF21KB

  • 09.04

Urgent Field Safety Notice for Vanguard XP Tibial Tray by Biomet Orthopedics, LLC

Non-active implants – bone surgery

PDF663KB

  • 09.04

Urgent Field Safety Notice for Monaco RTP System by IMPAC Medical Systems, Inc.

Radiotherapy / Radiation protection – radiotherapy treatment planning systems

PDF112KB

  • 09.04

Urgent Field Safety Notice for Barrier Sets by Mölnlycke Health Care AB

Surgical equipment/ Anaesthesia – surgical equipment

PDF4MB

  • 09.04

Urgent Field Safety Notice for Steril verpackte Sets mit Trägerschalen (Nierenschalen, Instrumentablett aus Faserformmaterial: Pappe) by Torunskie Zaklady Materialów Opatrunkowych SA

Dressings / Pads – others

PDF2MB

  • 09.03

Urgent Field Safety Notice for Blanketrol III by Gentherm Medical, LLC (formerly Cincinnati Sub-Zero)

Surgical equipment/ Anaesthesia – surgical equipment

PDF359KB

  • 09.03

Urgent Field Safety Notice for End Ball by Laboratoire ENDALIS

Non-active implants – special implants

PDF2MB

  • 09.03

Urgent Field Safety Notice for Drill Extension by Sirona Dental Systems GmbH

Dental products – instruments

PDF170KB

  • 09.03

Urgent Field Safety Notice for Steril verpackte Sets mit Trägerschalen (Nierenschalen, Instrumentablett aus Faserformmaterial: Pappe) by BSN medical GmbH

Dressings / Pads – others

PDF132KB

  • 09.03

Urgent Field Safety Notice for Blanketrol II by Gentherm Medical, LLC (formerly Cincinnati Sub-Zero)

Surgical equipment/ Anaesthesia – surgical equipment

PDF333KB

  • 09.02

Urgent Field Safety Notice for Modulus & Revision stems by Limacorporate S.p.A.

Non-active implants – bone surgery

PDF5MB

  • 09.02

Urgent Field Safety Notice for Flexavision F3 by Shimadzu Corporation

Radiological technology – stationary radiological equipment

PDF104KB

  • 08.30

Urgent Field Safety Notice for Cellognost Echinococcosis by Siemens Healthcare Diagnostics Products GmbH

In-vitro diagnostics – microbiological products

PDF420KB

  • 08.30

Urgent Field Safety Notice for SPROTTE Lumbal by PAJUNK GmbH Medizintechnologie

Injections / Infusions / Transfusions / Dialysis – injection kits

PDF148KB

  • 08.30

Urgent Field Safety Notice for UniCel DxH 800/600 Cellular Analysis Systems by Beckman Coulter, Inc.

In-vitro diagnostics – haematological, histological and cytological products

PDF197KB

  • 08.30

Urgent Field Safety Notice for AssayTip/AssayCup tray by Roche Diagnostics GmbH

In-vitro diagnostics – equipment / products for clinical chemistry

PDF677KB

  • 08.30

Urgent Field Safety Notice for VaccZyme Human Anti-Haemophilus Influenzae type b by The Binding Site Group Limited

In-vitro diagnostics – microbiological products

PDF202KB

  • 08.30

Urgent Field Safety Notice for Optilite C-Reactive Protein Reagent by The Binding Site Group Limited

In-vitro diagnostics – immunological products

PDF6MB

  • 08.30

Urgent Field Safety Notice for PreImpScreen PolB (13 16 18 21 22) by Kreatech Biotechnology B.V. / Leica Biosystems

In-vitro diagnostics – others

PDF162KB

  • 08.30

Urgent Field Safety Notice for AV-SET B-R & AV-Set SRB-R by Fresenius Medical Care AG & Co. KGaA

Injections / Infusions / Transfusions / Dialysis – dialysis technology

PDF50KB

  • 08.30

Urgent Field Safety Notice for Atellica CH 930 by Siemens Healthcare Diagnostics Inc. Tarrytown

In-vitro diagnostics – equipment / products for clinical chemistry

PDF328KB

  • 08.30

Urgent Field Safety Notice for Salivary Estrone ELISA by DRG Instruments GmbH

In-vitro diagnostics – immunological products

PDF2MB

  • 08.30

Urgent Field Safety Notice for BD FACSLyric Flow Cytometer by Becton, Dickinson and Company, BD Biosciences

In-vitro diagnostics – haematological, histological and cytological products

PDF232KB

  • 08.30

Urgent Field Safety Notice for LBgard Blood Collection Tube by Biomatrica, Inc.

In-vitro diagnostics – instruments, apparatuses and systems

PDF199KB

  • 08.30

Urgent Field Safety Notice for ORTHO Vision & Vision Max Analyzer by Ortho Clinical Diagnostics UK

In-vitro diagnostics – equipment / products for clinical chemistry

PDF411KB

  • 08.30

Urgent Field Safety Notice for Atellica IM Pregnancy-Associated Plasma Protein-A assay + Atellica IM anti-CCP IgG (aCCP) assay by Siemens Healthcare Diagnostics Inc. Tarrytown

In-vitro diagnostics – immunological products

PDF74KB

  • 08.29

Urgent Field Safety Notice for Trägerschalen (Nierenschalen, Instrumentablett aus Faserformmaterial: Pappe) für Steril verpackte Sets (MediTainer, MediBowl, MEdiDuo) by Omni-Pac Ekco GmbH

Dressings / Pads – others

PDF2MB

  • 08.29

Urgent Field Safety Notice for Prometra Programmable Pump by Flowonix Medical

Active implantable medical devices – drug pumps

PDF314KB

  • 08.28

Urgent Field Safety Notice for munevo DRIVE by munevo GmbH

Orthopaedic / Rehabilitation technology – mobility aids

PDF59KB

  • 08.28

Urgent Field Safety Notice for MONNAL T50, T40, T60, T75 by Air Liquide Medical Systems

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF166KB

  • 08.28

Urgent Field Safety Notice for Terumo Cardiopulmonary Extracorporeal Tubing Set Modular Perfusion Blood Circuit by Terumo Europe N.V.

Surgical equipment/ Anaesthesia – surgical equipment

PDF461KB

  • 08.28

Urgent Field Safety Notice for PrisMax Hemodialysis Machine by Baxter

Injections / Infusions / Transfusions / Dialysis – dialysis technology

PDF114KB

  • 08.28

Urgent Field Safety Notice for S.-System SCP CONTROL PANEL W/FAST CLAMP by LivaNova Deutschland GmbH

Surgical equipment/ Anaesthesia – surgical equipment

PDF71KB

  • 08.28

Urgent Field Safety Notice for InterVapor (TM) System, Generator by Uptake Medical Corp.

Physical therapy – others

PDF168KB

  • 08.27

Urgent Field Safety Notice for RadiForce by EIZO Corporation

Radiological technology – Radiological screen

PDF675KB

  • 08.27

Urgent Field Safety Notice for Powerflex PRO PTA balloon dilation by Cordis Corporation

Injections / Infusions / Transfusions / Dialysis – catheters

PDF1MB

  • 08.26

Urgent Field Safety Notice for TrapLiner Catheter by Vascular Solutions, Inc.

Injections / Infusions / Transfusions / Dialysis – catheters

PDF175KB

  • 08.26

Urgent Field Safety Notice for REX Cement Stop by Spierings Orthopaedics B.V

Non-active implants – bone surgery

PDF3MB

  • 08.26

Urgent Field Safety Notice for FeNO+ by Medisoft S.A.

Medical electronics / Electromedical devices – pulmonary function diagnostics

PDF223KB

  • 08.26

Urgent Field Safety Notice for Endorektalspulen (endo-rectal coils) by RAPID Biomedical GmbH

Electromedical fields – equipment for magnet therapy

PDF1MB

  • 08.26

Urgent Field Safety Notice for Norm-O-Temp by Gentherm Medical, LLC (formerly Cincinnati Sub-Zero)

Surgical equipment/ Anaesthesia – surgical equipment

PDF2MB

  • 08.26

Urgent Field Safety Notice for UROMED-Katheterisierungs-Besteck (inkl. Papp-Nierenschalen) by UROMED Kurt Drews KG

General equipment for medical treatment – others

PDF5MB

  • 08.26

Urgent Field Safety Notice for Monaco RTP System by IMPAC Medical Systems, Inc.

Radiotherapy / Radiation protection – radiotherapy treatment planning systems

PDF56KB

  • 08.26

Urgent Field Safety Notice for Calcar Planar Shaft-BIOMET by Biomet UK Ltd

Medical instruments for use in humans – bone surgery

PDF170KB

  • 08.26

Urgent Field Safety Notice for Concerto & Basic Shower Trolley by ArjoHuntleigh AB Malmö

Orthopaedic / Rehabilitation technology – daily living aids

PDF494KB

  • 08.26

Urgent Field Safety Notice for EMBLEM S-ICD and EMBLEM MRI S-ICD by Cardiac Pacemaker Inc.- A wholly owned subsidiary of Guidant Corporation – A wholly owned subsidiary

Active implantable medical devices – defibrillators

PDF577KB

  • 08.26

Urgent Field Safety Notice for Catheter Ureteric by Rocket Medical plc

Injections / Infusions / Transfusions / Dialysis – catheters

PDF531KB

  • 08.26

Urgent Field Safety Notice for Sidus Stem-Free Shoulder Humeral Head by Zimmer GmbH

Non-active implants – bone surgery

PDF239KB

  • 08.26

Urgent Field Safety Notice for Giraffe OmniBed by GE Healthcare Clinical Systems (Ohmeda Medical)

Physical therapy – climatotherapy

PDF208KB

  • 08.22

Urgent Field Safety Notice for Sterile Absorbent cotton O.R towels by Medline International France SAS

Surgical equipment/ Anaesthesia – surgical equipment

PDF29KB

  • 08.22

Urgent Field Safety Notice for Rollator by Aspiria Nonfood GmbH

Orthopaedic / Rehabilitation technology – daily living aids

PDF1MB

  • 08.22

Urgent Field Safety Notice for LogiCal Pressure Monitoring Kit by Smiths Medical ASD, Inc. (Plymouth)

Medical electronics / Electromedical devices – electronic blood pressure monitor

PDF823KB

  • 08.21

Urgent Field Safety Notice for VIDAS FT4 by bioMérieux S. (Marcy- l’Etoile)

In-vitro diagnostics – immunological products

PDF103KB

  • 08.21

Urgent Field Safety Notice for Snap Leadwire & Gold Cup electrodes by Med-Dyne, Inc.

Medical electronics / Electromedical devices – electrodiagnostics

PDF301KB

  • 08.21

Urgent Field Safety Notice for Steam sterilizer by Getinge Sterilization AB

General equipment for medical treatment – cleaning / disinfection / sterilisation

PDF37KB

  • 08.21

Urgent Field Safety Notice for Estrone Saliva ELISA by IBL International GmbH

In-vitro diagnostics – immunological products

PDF173KB

  • 08.21

Urgent Field Safety Notice for Atellica CH 930 by Siemens Healthcare Diagnostics Inc. Tarrytown

In-vitro diagnostics – equipment / products for clinical chemistry

PDF85KB

  • 08.21

Urgent Field Safety Notice for Alinity i Total ß-hCG Reagent Kit by Abbott Ireland Diagnostics Division

In-vitro diagnostics – immunological products

PDF127KB

  • 08.21

Urgent Field Safety Notice for ThermoScientific Oxoid Meropenem 32 M.I.C.E. by Remel Europe Ltd

In-vitro diagnostics – microbiological products

PDF400KB

  • 08.19

Urgent Field Safety Notice for FTD Neuro 9 by Fast Track Diagnostics Luxembourg S.à.r.l

In-vitro diagnostics – microbiological products

PDF202KB

  • 08.19

Urgent Field Safety Notice for Cooltechnology by High Technologie Products S.L.U

Physical therapy – climatotherapy

PDF65KB

  • 08.16

Urgent Field Safety Notice for Triathlon by Howmedica Osteonics Corporation

Non-active implants – bone surgery

PDF188KB

  • 08.16

Urgent Field Safety Notice for EV1000 Clinical Platform System by Edwards Lifesciences LLC

Medical electronics / Electromedical devices – electrodiagnostics

PDF516KB

  • 08.16

Urgent Field Safety Notice for QUADROX-i Neonatal Microporous Membrane Oxygenator by Maquet Cardiopulmonary AG

Surgical equipment/ Anaesthesia – surgical equipment

PDF2MB

  • 08.16

Urgent Field Safety Notice for Medizym T.R.A. human by MEDIPAN GMBH

In-vitro diagnostics – immunological products

PDF231KB

  • 08.16

Urgent Field Safety Notice for INFUSOMAT S.. LINE,TRANSF.,PVC,LL,250CM by B. Braun Melsungen AG

Injections / Infusions / Transfusions / Dialysis – infusion technology

PDF39KB

  • 08.16

Urgent Field Safety Notice for Sets mit Papp-Nierenschalen by Angiokard Medizintechnik GmbH

General equipment for medical treatment – others

PDF26KB

  • 08.16

Urgent Field Safety Notice for RABEA PEEK Cervical cage angled, 6x12x14mm 5° by Signus Medizintechnik GmbH

Non-active implants – bone surgery

PDF209KB

  • 08.16

Urgent Field Safety Notice for ALLUX by Nabtesco Corporation

Orthopaedic / Rehabilitation technology – prostheses (exoprostheses)

PDF164KB

  • 08.16

Urgent Field Safety Notice for Accu-Chek Insight by Roche Diabetes Care GmbH

Injections / Infusions / Transfusions / Dialysis – infusion technology

PDF81KB

  • 08.16

Urgent Field Safety Notice for IMACTIS Single Use Navigation Kit by IMACTIS

Radiological technology – navigation systems

PDF296KB

  • 08.16

Urgent Field Safety Notice for HEMOSPRAY ENDOSCOPIC HEMOSTAT by Cook Endoscopy

Non-active implants – special implants

PDF94KB

  • 08.16

Urgent Field Safety Notice for Surgical Base System by Medineering GmbH

Surgical equipment/ Anaesthesia – surgical equipment

PDF2MB

  • 08.16

Urgent Field Safety Notice for Varian Multileaf Collimator [MLC] by Varian Medical Systems, Inc.

Radiological technology – equipment for nuclear medical functional and localisation diagnostics

PDF159KB

  • 08.19

Urgent Field Safety Notice for FTD Neuro 9 by Fast Track Diagnostics Luxembourg S.à.r.l

In-vitro diagnostics – microbiological products

PDF202KB

  • 08.19

Urgent Field Safety Notice for Cooltechnology by High Technologie Products S.L.U

Physical therapy – climatotherapy

PDF65KB

  • 08.16

Urgent Field Safety Notice for Triathlon by Howmedica Osteonics Corporation

Non-active implants – bone surgery

PDF188KB

  • 08.16

Urgent Field Safety Notice for EV1000 Clinical Platform System by Edwards Lifesciences LLC

Medical electronics / Electromedical devices – electrodiagnostics

PDF516KB

  • 08.16

Urgent Field Safety Notice for QUADROX-i Neonatal Microporous Membrane Oxygenator by Maquet Cardiopulmonary AG

Surgical equipment/ Anaesthesia – surgical equipment

PDF2MB

  • 08.16

Urgent Field Safety Notice for Medizym T.R.A. human by MEDIPAN GMBH

In-vitro diagnostics – immunological products

PDF231KB

  • 08.16

Urgent Field Safety Notice for INFUSOMAT S.. LINE,TRANSF.,PVC,LL,250CM by B. Braun Melsungen AG

Injections / Infusions / Transfusions / Dialysis – infusion technology

PDF39KB

  • 08.16

Urgent Field Safety Notice for Sets mit Papp-Nierenschalen by Angiokard Medizintechnik GmbH

General equipment for medical treatment – others

PDF26KB

  • 08.16

Urgent Field Safety Notice for RABEA PEEK Cervical cage angled, 6x12x14mm 5° by Signus Medizintechnik GmbH

Non-active implants – bone surgery

PDF209KB

  • 08.16

Urgent Field Safety Notice for ALLUX by Nabtesco Corporation

Orthopaedic / Rehabilitation technology – prostheses (exoprostheses)

PDF164KB

  • 08.16

Urgent Field Safety Notice for Accu-Chek Insight by Roche Diabetes Care GmbH

Injections / Infusions / Transfusions / Dialysis – infusion technology

PDF81KB

  • 08.16

Urgent Field Safety Notice for IMACTIS Single Use Navigation Kit by IMACTIS

Radiological technology – navigation systems

PDF296KB

  • 08.16

Urgent Field Safety Notice for HEMOSPRAY ENDOSCOPIC HEMOSTAT by Cook Endoscopy

Non-active implants – special implants

PDF94KB

  • 08.16

Urgent Field Safety Notice for Surgical Base System by Medineering GmbH

Surgical equipment/ Anaesthesia – surgical equipment

PDF2MB

  • 08.16

Urgent Field Safety Notice for Varian Multileaf Collimator [MLC] by Varian Medical Systems, Inc.

Radiological technology – equipment for nuclear medical functional and localisation diagnostics

PDF159KB

  • 08.13

Urgent Field Safety Notice for Oxoid Staphytect plus by Remel Europe Ltd

In-vitro diagnostics – microbiological products

PDF395KB

  • 08.13

Urgent Field Safety Notice for URINALYSIS CONTROL – LEVEL 2 by Randox Laboratories Ltd

In-vitro diagnostics – equipment / products for clinical chemistry

PDF1MB

  • 08.13

Urgent Field Safety Notice for FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor by Agilent Technologies Denmark ApS

In-vitro diagnostics – immunological products

PDF126KB

  • 08.12

Urgent Field Safety Notice for Optilite IgM Kit by The Binding Site Group Limited

In-vitro diagnostics – equipment / products for clinical chemistry

PDF472KB

  • 08.12

Urgent Field Safety Notice for A7 Mycoplasma Agar (MYCO) by bioMerieux Inc US

In-vitro diagnostics – microbiological products

PDF386KB

  • 08.12

Urgent Field Safety Notice for Seralite – FLC Serum_ SKL0025 by Abingdon Health Ltd

In-vitro diagnostics – immunological products

PDF244KB

  • 08.12

Urgent Field Safety Notice for ADVIA Centaur Folate Assay by Siemens Healthcare Diagnostics Inc. Tarrytown

In-vitro diagnostics – equipment / products for clinical chemistry

PDF230KB

  • 08.12

Urgent Field Safety Notice for r ex-tem Reagenz by Tem Innovations GmbH

In-vitro diagnostics – haematological, histological and cytological products

PDF1MB

  • 08.12

Urgent Field Safety Notice for AQURE system by Radiometer Medical ApS

In-vitro diagnostics – equipment / products for clinical chemistry

PDF51KB

  • 08.12

Urgent Field Safety Notice for Stratus® CS Acute CareTM CTNI TestPak by Siemens Healthcare Diagnostics Inc.

In-vitro diagnostics – immunological products

PDF890KB

  • 08.12

Urgent Field Safety Notice for cobas t511/t711 + Cuvette COBAS INTEGRA by Roche Diagnostics GmbH

In-vitro diagnostics – haematological, histological and cytological products

PDF507KB

  • 08.08

Urgent Field Safety Notice for SATURNE tripolar cup – Cemented by Amplitude S.A.S.

Non-active implants – bone surgery

PDF401KB

  • 08.08

Urgent Field Safety Notice for Life Scope G9 by Nihon Kohden Corp.

Medical electronics / Electromedical devices – electrodiagnostics

PDF967KB

  • 08.08

Urgent Field Safety Notice for Philips Azurion system by Philips Medical Systems Nederland B.V.

Radiological technology – radiological equipment for vascular diagnostics

PDF325KB

  • 08.08

Urgent Field Safety Notice for Life Scope G9 by Nihon Kohden Corp.

Medical electronics / Electromedical devices – electrodiagnostics

PDF189KB

  • 08.08

Urgent Field Safety Notice for Life Scope G5 und Life Scope G7 by Nihon Kohden Corp.

Medical electronics / Electromedical devices – electrodiagnostics

PDF177KB

  • 08.08

Urgent Field Safety Notice for SPECTRALIS by Heidelberg Engineering GmbH

ophthalmological technology – equipment for ophthalmological diagnostics

PDF2MB

  • 08.06

Urgent Field Safety Notice for syngo.via by Siemens Healthcare GmbH, SYNGO (SY)

Radiological technology – auxiliary equipment and supplies for radiology / nuclear medicine

PDF3MB

  • 08.06

Urgent Field Safety Notice for Ingenuity CT, Ingenuity Core, Ingenuity Core128 by Philips Healthcare (Cleveland)

Radiological technology – CT scanners

PDF295KB

  • 08.06

Urgent Field Safety Notice for Philips Azurion system by Philips Medical Systems Nederland B.V.

Radiological technology – radiological equipment for vascular diagnostics

PDF349KB

  • 08.06

Urgent Field Safety Notice for BrightView, BrightView X, BrightView XCT by Philips Healthcare (Cleveland)

Radiological technology – equipment for nuclear medical functional and localisation diagnostics

PDF614KB

  • 08.02

Urgent Field Safety Notice for Serofine by B. Braun Melsungen AG

Injections / Infusions / Transfusions / Dialysis – injection kits

PDF1MB

  • 08.02

Urgent Field Safety Notice for Monnal T60 by Air Liquide Medical Systems

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF172KB

  • 08.02

Urgent Field Safety Notice for IONTRIS by Siemens Healthcare GmbH, Advanced Therapies, Particle Therapy

Radiotherapy / Radiation protection – nuclear medical therapeutic equipment

PDF149KB

  • 08.01

Urgent Field Safety Notice for Six titanium abutments, see Attachment I by Nobel Biocare AB

Dental products – dental implants

PDF39KB

  • 08.01

Urgent Field Safety Notice for da Vinci Xi and da Vinci X Surgical System by Intuitive Surgical, Inc.

Surgical equipment/ Anaesthesia – surgical equipment

PDF650KB

  • 07.31

Urgent Field Safety Notice for Mölnlycke Exufiber Ag+ by Mölnlycke Health Care AB

Dressings / Pads – ointments and gels

PDF120KB

  • 07.31

Urgent Field Safety Notice for Panetti Saug-Rundschnittmesser 45°, 2,5 mm, 13 cm, Luer-Lock Saugöffnung Winkelinnenseite by Spiggle & Theis Medizintechnik GmbH

Medical electronics / Electromedical devices – electrotherapy

PDF352KB

  • 07.31

Urgent Field Safety Notice for Allofit-S, Alloclassic, shell with polar screw pl by Zimmer GmbH

Non-active implants – bone surgery

PDF267KB

  • 07.31

Urgent Field Safety Notice for syngo.via by Siemens Healthcare GmbH, SYNGO (SY)

Radiological technology – auxiliary equipment and supplies for radiology / nuclear medicine

PDF2MB

  • 07.31

Urgent Field Safety Notice for Diverse Swivel Produkte by Intersurgical Ltd.

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF144KB

  • 07.30

Urgent Field Safety Notice for MAC VU360 by GE Healthcare Information Technologies GmbH

Medical electronics / Electromedical devices – electrodiagnostics

PDF241KB

  • 07.30

Urgent Field Safety Notice for TIVITA Tissue by Diaspective Vision GmbH

Medical data processing (software) – data processing facilities for image processing

PDF165KB

  • 07.30

Urgent Field Safety Notice for AMPLIVISION – Fixation K+-wire Ø4 by Amplitude S.A.S.

Medical instruments for use in humans – bone surgery

PDF725KB

  • 07.30

Urgent Field Safety Notice for Artis zee/Q/Q.zen systems by Siemens Healthcare GmbH Advanced Therapies

Radiological technology – radiological equipment for vascular diagnostics

PDF1,013KB

  • 07.29

Urgent Field Safety Notice for Dimension Ferritin Flex reagent cartridge by Siemens Healthcare Diagnostics Inc. Newark

In-vitro diagnostics – immunological products

PDF64KB

  • 07.29

Urgent Field Safety Notice for ONLINE TDM Vancomycin Gen.3 (VANC3) by Roche Diagnostics GmbH

In-vitro diagnostics – equipment / products for clinical chemistry

PDF283KB

  • 07.29

Urgent Field Safety Notice for Phadia 1000 by Phadia AB

In-vitro diagnostics – equipment / products for clinical chemistry

PDF70KB

  • 07.29

Urgent Field Safety Notice for Lithium, Alinity c Lithium Reagent Kit by SENTINEL CH. SpA

In-vitro diagnostics – equipment / products for clinical chemistry

PDF2MB

  • 07.29

Urgent Field Safety Notice for Calibration Serum Level 3 _ CAL2351 by Randox Laboratories Ltd

In-vitro diagnostics – equipment / products for clinical chemistry

PDF2MB

  • 07.29

Urgent Field Safety Notice for BD Max Reagents by GeneOhm Sciences Canada, Inc.

In-vitro diagnostics – microbiological products

PDF282KB

  • 07.29

Urgent Field Safety Notice for Remel Salmonella paratyphi B-H by Remel Europe Ltd

In-vitro diagnostics – microbiological products

PDF396KB

  • 07.29

Urgent Field Safety Notice for Occlutech Delivery Set by Occlutech GmbH

Non-active implants – cardiac surgery

PDF2MB

  • 07.29

Urgent Field Safety Notice for OEC Fluorostar,OEC Fluorostar Compact,OEC Fluorost by GE OEC Medical Systems GmbH

Radiological technology – mobile radiological diagnostic facilities

PDF216KB

  • 07.26

Urgent Field Safety Notice for Stainless steel needle 200 mm, 17 gauge, trocar by Varian Medical Systems, Inc.

Radiotherapy / Radiation protection – nuclear medical therapeutic equipment

PDF174KB

  • 07.26

Urgent Field Safety Notice for Mammomat Revelation by Siemens Healthcare GmbH Advanced Therapies

Radiological technology – radiological equipment for mammographic diagnostics

PDF3MB

  • 07.25

Urgent Field Safety Notice for Cartilage Microtome System by Grace Medical, Inc.

Medical instruments for use in humans – bone surgery

PDF135KB

  • 07.24

Urgent Field Safety Notice for Elecsys Anti-CCP (Modular Analytics E170, cobas e411, cobas e 601, cobas e 602, 100 tests) 05031656190. Lots: 368033, 376804, 389152, Elecsys Anti-CCP (cobas e 801, 100 tests) 072 by Roche Diagnostics GmbH

In-vitro diagnostics – immunological products

PDF254KB

  • 07.24

Urgent Field Safety Notice for cobas t 511 and t 711 – Coagulation analyzer by Roche Diagnostics GmbH

In-vitro diagnostics – haematological, histological and cytological products

PDF449KB

  • 07.24

Urgent Field Safety Notice for QIAsymphony S. by QIAGEN GmbH

In-vitro diagnostics – haematological, histological and cytological products

PDF438KB

  • 07.24

Urgent Field Safety Notice for BD Max Reagents by BD & Co.  Sparks MD

In-vitro diagnostics – microbiological products

PDF280KB

  • 07.24

Urgent Field Safety Notice for IMMULITE/IMMULITE 1000/IMMULITE2000/IMMULITE 2000XPi by Siemens Medical Solutions Diagnostics

In-vitro diagnostics – immunological products

PDF42KB

  • 07.24

Urgent Field Safety Notice for Dexcom G4 PLATINUM, Dexcom G5 Mobile by Dexcom, Inc.

Medical electronics / Electromedical devices – electric blood glucose meters

PDF304KB

  • 07.24

Urgent Field Safety Notice for TransWarmer Infant Transport Mattress by Cooper Surgical Inc.

General equipment for medical treatment – furnishings

PDF761KB

  • 07.24

Urgent Field Safety Notice for SOMATOM go.Up, go.TOP, go.ALL by Siemens Healthcare GmbH Computed Tomography (CT)

Radiological technology – CT scanners

PDF5MB

  • 07.23

Urgent Field Safety Notice for MobileDaRt Evolution by Shimadzu Corporation

Radiological technology – mobile radiological diagnostic facilities

PDF153KB

  • 07.23

Urgent Field Safety Notice for Vereos PET/CT by PHILIPS MEDICAL SYSTEMS (Cleveland), Inc. (CL)

Radiological technology – CT scanners

PDF54KB

  • 07.23

Urgent Field Safety Notice for Sauerstoffkatheter CH10 by ASSAmed GmbH

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF93KB

  • 07.22

Urgent Field Safety Notice for motion cycle 600 med by emotion fitness GmbH & Co. KG

Medical electronics / Electromedical devices – functional diagnostics by way of gas exchange and exercise

PDF181KB

  • 07.22

Urgent Field Safety Notice for BIB/Orbera365 Intragastric Balloon Systems by apollo endosurgery

Non-active implants – special implants

PDF67KB

  • 07.19

Urgent Field Safety Notice for VisualaseT Thermal Therapy System by Medtronic Navigation Inc.

Optics / Precision engineering – laser technology

PDF49KB

  • 07.19

Urgent Field Safety Notice for C-10 Probetester by ES-Medical AB

General equipment for medical treatment – cleaning / disinfection / sterilisation

PDF84KB

  • 07.18

Urgent Field Safety Notice for Nierenschale, Pappe by Vivomed GmbH

General equipment for medical treatment – others

PDF96KB

  • 07.18

Urgent Field Safety Notice for Quantum Pump Concole by Spectrum Medical Ltd.

Surgical equipment/ Anaesthesia – surgical equipment

PDF829KB

  • 07.18

Urgent Field Safety Notice for CareLink Programmer; CareLink Encore Programmer by Medtronic Inc

Active implantable medical devices – defibrillators

PDF825KB

  • 07.17

Urgent Field Safety Notice for FilmArray Gastrointestinal (GI) Panel by BioFire Diagnostics, LLC

In-vitro diagnostics – microbiological products

PDF338KB

  • 07.17

Urgent Field Safety Notice for BeneHeart D1 Defibrilator/Monitor by SHENZSHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD

Medical electronics / Electromedical devices – electrotherapy

PDF147KB

  • 07.17

Urgent Field Safety Notice for VIKIA Malaria Ag Pf/Pan by bioMérieux S. (Marcy- l’Etoile)

In-vitro diagnostics – microbiological products

PDF209KB

  • 07.17

Urgent Field Safety Notice for BILD2 (Bilirubin direct Gen.2) by Roche Diagnostics GmbH

In-vitro diagnostics – equipment / products for clinical chemistry

PDF405KB

  • 07.17

Urgent Field Safety Notice for HexaPOD evo RT System / Medical Intelligence Mediz by Elekta | Medical Intelligence Medizintechnik GmbH

Surgical equipment/ Anaesthesia – surgical equipment

PDF181KB

  • 07.17

Urgent Field Safety Notice for Edwards Ultra Delivery System by Edwards Lifesciences LLC

Injections / Infusions / Transfusions / Dialysis – catheters

PDF91KB

  • 07.17

Urgent Field Safety Notice for Führungsdraht by EPflex Feinwerktechnik GmbH

Injections / Infusions / Transfusions / Dialysis – catheters

PDF455KB

  • 07.17

Urgent Field Safety Notice for FTlyo diverse by Fast Track Diagnostics Luxembourg S.à.r.l

In-vitro diagnostics – instruments, apparatuses and systems

PDF99KB

  • 07.17

Urgent Field Safety Notice for COBAS INTEGRA® 400 plus analyzer with ISE, model number: 03245233001 COBAS INTEGRA ® 400 plus analyzer w/o (without) ISE, model number: 04922859001 by Roche Diagnostics GmbH

In-vitro diagnostics – equipment / products for clinical chemistry

PDF130KB

  • 07.17

Urgent Field Safety Notice for Intraclude device by Edwards Lifesciences Utah

Injections / Infusions / Transfusions / Dialysis – catheters

PDF261KB

  • 07.17

Urgent Field Safety Notice for Mikrobac Virucidal Tissues by BODE Chemie GmbH

General equipment for medical treatment – cleaning / disinfection / sterilisation

PDF388KB

  • 07.17

Urgent Field Safety Notice for ECG trunk cables, ECG Leadwires by GE Healthcare Finland Oy

Medical electronics / Electromedical devices – electrotherapy

PDF293KB

  • 07.16

Urgent Field Safety Notice for Kiwi Complete Vacuum Delivery System by Clinical Innovations, LLC

Medical instruments for use in humans – gynaecology

PDF1MB

  • 07.16

Urgent Field Safety Notice for DermaFC by Magnosco GmbH

Optics / Precision engineering – laser technology

PDF1MB

  • 07.16

Urgent Field Safety Notice for DISCOVERY Elbow – Humeral condyle kit XS CoCrMo + by Limacorporate S.p.A.

Non-active implants – bone surgery

PDF1MB

  • 07.16

Urgent Field Safety Notice for iLA activve Kits / iLA activve iLA Kit by Xenios AG

Surgical equipment/ Anaesthesia – surgical equipment

PDF1MB

  • 07.12

Urgent Field Safety Notice for GS defibrillation electrodes by Leonhard Lang Medizintechnik GmbH

Medical electronics / Electromedical devices – electrotherapy

PDF472KB

  • 07.11

Urgent Field Safety Notice for Ellipse VR, Ellipse DR by S.. Jude Medical CRMD

Active implantable medical devices – defibrillators

PDF27KB

  • 07.11

Urgent Field Safety Notice for SCHNEIDE-ELEKTRODE MONO 11,5CH 0° by Richard Wolf GmbH

Medical electronics / Electromedical devices – electrotherapy

PDF817KB

  • 07.11

Urgent Field Safety Notice for Pulsavac Plus Wound Debridement System Hip Kit by Zimmer Orthopaedic Surgical Products

Surgical equipment/ Anaesthesia – surgical equipment

PDF114KB

  • 07.11

Urgent Field Safety Notice for Medtronic MiniMed Paradigm Infusion Pumps; Medtronic MiniMed Paradigm VEOTM; Medtronic MiniMed Infusion Pump by Medtronic Minimed

Injections / Infusions / Transfusions / Dialysis – infusion technology

PDF145KB

  • 07.10

Urgent Field Safety Notice for cobas 6800 system, cobas 8800 system by Roche Diagnostics GmbH

In-vitro diagnostics – equipment / products for clinical chemistry

PDF479KB

  • 07.10

Urgent Field Safety Notice for GRIPPER and PORT-A-CATH Needles by Smiths Medical ASD, lnc.

Injections / Infusions / Transfusions / Dialysis – injection kits

PDF350KB

  • 07.09

Urgent Field Safety Notice for GTS Trunnion Rasp by Biomet France SARL

Medical instruments for use in humans – bone surgery

PDF2MB

  • 07.09

Urgent Field Safety Notice for ORTHO AutoVue Innova Ultra & VISION VISION Max by Ortho Clinical Diagnostics (Bridgend)

In-vitro diagnostics – equipment / products for clinical chemistry

PDF229KB

  • 07.09

Urgent Field Safety Notice for NC-Infant ENFit-Ernährungssonde, PUR (5Fr/50cm) by GBUK Group Ltd.

Injections / Infusions / Transfusions / Dialysis – probes

PDF779KB

  • 07.09

Urgent Field Safety Notice for FTD ACE by Fast Track Diagnostics Luxembourg S.à.r.l

In-vitro diagnostics – microbiological products

PDF2MB

  • 07.09

Urgent Field Safety Notice for Alere DDS2 Test Kit by Alere Toxicology Plc

In-vitro diagnostics – equipment / products for clinical chemistry

PDF389KB

  • 07.09

Urgent Field Safety Notice for VIP RIA (Vasoactive intestinal polypeptide) by DIAsource ImmunoAssays S.A.

In-vitro diagnostics – immunological products

PDF265KB

  • 07.09

Urgent Field Safety Notice for Monaco RTP System by IMPAC Medical Systems, Inc.

Radiotherapy / Radiation protection – radiotherapy treatment planning systems

PDF69KB

  • 07.09

Urgent Field Safety Notice for E.MOTION UC/PS TIB.PLAT.C’LESS µCAP T7R by Aesculap AG

Non-active implants – bone surgery

PDF90KB

  • 07.09

Urgent Field Safety Notice for Yumizen H2500, YumizenH1500 by HORIBA ABX SAS

In-vitro diagnostics – haematological, histological and cytological products

PDF221KB

  • 07.09

Urgent Field Safety Notice for TACTYS – IPP Prosthesis -Proximal Surface by Stryker Trauma AG

Non-active implants – bone surgery

PDF68KB

  • 07.09

Urgent Field Safety Notice for Tests based on NAD(H)/NADP(H) reaction, see ca..no by Thermo Fisher Scientific Oy

In-vitro diagnostics – equipment / products for clinical chemistry

PDF3MB

  • 07.05

Urgent Field Safety Notice for da Vinci Xi EndoWrist SureForm 60 Reload by Intuitive Surgical, Inc.

Surgical equipment/ Anaesthesia – surgical equipment

PDF550KB

  • 07.05

Urgent Field Safety Notice for LANTIS by Siemens Healthcare GmbH, Advanced Therapies, Radiation Oncology

Radiotherapy / Radiation protection – radiotherapy treatment planning systems

PDF42KB

  • 07.05

Urgent Field Safety Notice for Anaesthesia conduction filter by B. Braun Melsungen AG

Injections / Infusions / Transfusions / Dialysis – injection kits

PDF55KB

  • 07.04

Urgent Field Safety Notice for Intraluminal Staplers (ILS) by Ethicon Endo-Surgery, LLC.

Medical instruments for use in humans – general instruments

PDF396KB

  • 07.04

Urgent Field Safety Notice for Grundhalterung für Spannbohrbuchse, LOQTEQ 4.5, Rundloch/Basic insert for load drill guide, LOQTEQ 4.5, round hole by aap Implantate AG

Non-active implants – bone surgery

PDF3MB

  • 07.03

Urgent Field Safety Notice for MAGEC Spinal Bracing and Distraction System by NuVasive Specialized Orthopedics, Inc., a division of NuVasive, Inc.

Active implantable medical devices – others

PDF568KB

  • 07.03

Urgent Field Safety Notice for Edwards CENTERA Transcatheter Heart Valve System by Edwards Lifesciences LLC

Non-active implants – cardiac surgery

PDF174KB

  • 07.03

Urgent Field Safety Notice for Charging System, RestoreSensor Charging System by Medtronic Inc.

Active implantable medical devices – biostimulators

PDF126KB

  • 07.03

Urgent Field Safety Notice for Somatom Force by Siemens Healthcare GmbH Computed Tomography (CT)

Radiological technology – CT scanners

PDF2MB

  • 07.03

Urgent Field Safety Notice for Nurses Control Panel Arm – Long by KeyMed (Medical & Industrieal Equipment Ltd.)

Surgical equipment/ Anaesthesia – surgical equipment

PDF7MB

  • 07.03

Urgent Field Safety Notice for WS80A, HS70A by SAMSUNG MEDISON CO., LTD.

Ultrasonics – ultrasonic diagnostic equipment

PDF158KB

  • 07.03

Urgent Field Safety Notice for SDMS (SenTec Digital Monitoring System) by SenTec AG

Medical electronics / Electromedical devices – electrodiagnostics

PDF202KB

  • 07.01

Urgent Field Safety Notice for QIAsymphony Filter Tips, 1500µl (1024) by QIAGEN GmbH

In-vitro diagnostics – equipment / products for clinical chemistry

PDF92KB

  • 07.01

Urgent Field Safety Notice for Sheridan ET Tubes by Teleflex Medical USA

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF348KB

  • 07.01

Urgent Field Safety Notice for Solution (Kit) by REPROLIFE

Physical therapy – others

PDF157KB

 

 

Швейцарія

https://fsca.swissmedic.ch/mep/#/

 

30.09.2019

SEBAG SENECTOVIA Medizinaltechnik AG

Phoenix Ergocare Intensiv-Pflegebett

MD: Beds; Beds, Electric; Beds, Electric,Obese

DE-1

Vk_20190930_16

27.09.2019

Lohmann & Rauscher GmbH & Co. KG

Cardboard Kidney Shell in KitPack (set system)
Lot: all sets sytems with running expiry date

MD: Bowls, Sponge Collection

DE-1

Vk_20190923_05

27.09.2019

CooperSurgical Inc.

Embryology Heated Plate within the RI WitnessTM
Model: 6-70-807, 6-70-807-A, 6-70-807-B
S/N: See FSN

MD: Assisted reproduction heater/incubator

DE-1
FR-1
IT-1
EN-1

Vk_20190920_16

26.09.2019 

(Updated 27.09.2019)

Smith & Nephew Orthopaedics AG

RT-PLUS MODULAR FEMORAL BLOCK
Model: 75005579; 75005585; 75005587
Lot: D1416197; D1416198; D1416199

MD: Knee arthroplasty wedge

DE-1
FR-1
IT-1
EN-1

Vk_20190920_03

27.09.2019

Axis-Shield Diagnostics Limited

Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE
Model: FHBC100, FHRWR100/200/1000
Lot: 902924530, 902925703, 902924526, 902925702, 902924829

IVD: Homocysteine IVD, reagent

EN-1

Vk_20190917_08

26.09.2019

Siemens Healthcare Diagnostics Inc

Atellica 1500 Automated Urinalysis System

Atellica UAS 800 analyzer
Model: SMN 11065004
Lot: N/A
S/N: N/A
SW-Version: All versions up to and including V4.0.220

IVD: Urine analyser IVD, laboratory, automated

IVD: Urine analyser IVD, laboratory, automated

FR-1
EN-1

Vk_20190923_12

26.09.2019

Hain Lifesciences GmbH

Substrate Buffer (SUB-D) of the GenoType Test Systems from Hain Lifescience GmbH
Model: 88896, 34496, 29996A, 23396, 34196, 25296, 24196, 23296, 33796, 30196, 29596, 24596, 29796, 29896, 29996, 31796, 30496AGL, 30496A
Lot: SUB-D lot numbers G0119 and G0319

IVD: Buffers

EN-1

Vk_20190923_01

25.09.2019

Bühlmann Laboratories AG

BÜHLMANN GanglioCombi MAG ELISA
Model: EK-GCM
Lot: 2030, 2030.1, 2131

IVD: Ganglioside total antibody IVD, kit, enzyme immunoassay (EIA)

EN-1

Vk_20190918_05

25.09.2019

Codman & Shurtleff, Inc

Codman ISOCOOL AHT Bipolar Forceps Tips
Model: 8145100S
Lot: J2670Y

MD: Open-surgery electrosurgical handpiece/electrode, bipolar, single-use

FR-1
EN-1

Vk_20190918_01

10.09.2019 

(Updated 23.09.2019)

Medtronic Inc.

Euphora and Solarice Rapid Exchange Balloon Dilatation Catheter
Model: See FSN
Lot: See FSN

MD: Coronary angioplasty balloon catheter, basic

DE-1
FR-1
EN-1

Vk_20190909_06

30.08.2019 

(Updated 23.09.2019)

Beckman Coulter

Triglycerides GPO Blanked
Model: 445850
Lot: all

Urin Acid
Model: 442785
Lot: all

Total Bilirubin
Model: 442745, 476861
Lot: all

Direct Bilirubin
Model: 439715, 476856
Lot: all

Enzymatic Creatinine
Model: A602298
Lot: all

IVD: Triglyceride IVD, kit, enzyme spectrophotometry

IVD: Uric acid IVD, kit, enzyme spectrophotometry

IVD: Total bilirubin IVD, kit, spectrophotometry

IVD: Conjugated (direct) bilirubin IVD, kit, spectrophotometry

IVD: Creatinine IVD, kit, enzyme spectrophotometry

DE-2
FR-1
EN-1

Vk_20190823_01

20.09.2019

MedTech – Zimmer Biomet Robotics

ROSA Brain
S/N: BR16027, BR16028, BR17033, BR16029
SW-Version: 3.0.0.21

MD: Neurological stereotactic surgery system

FR-1
EN-1

Vk_20190913_11

20.09.2019

Gentherm Medical, LLC (formerly Cincinnati Sub-Zero)

Blanketrol III
Model: 86001, 86203, 86204, 86207
S/N: All Blanketrol III manufactured in the past 12 years.

MD: Circulating-fluid whole-body heating/cooling system control unit

DE-1
FR-1
IT-1

Vk_20190912_07

20.09.2019

Johnson & Johnson Vision Care

1-DAY ACUVUE MOIST for Astigmatism
Lot: 395749, 395750, 395751

MD: Soft corrective contact lens, daily-disposable

DE-1
FR-1
IT-1

Vk_20190911_06

19.09.2019

ArcRoyal uc, an Owens and Minor Company

Medline Sterile Absorbent Cotton O.R Towels
Model: 10-007081

MD: Surgical towel

DE-1
EN-1

Vk_20190916_28

18.09.2019

Abbott Ireland Diagnostic Division

Alinity i STAT Myoglobin Reagent Kit
Model: 04V3720
Lot: 04436FN00

IVD: Myoglobin IVD, kit, chemiluminescent immunoassay

EN-1

Vk_20190910_16

18.09.2019

HemoCue AB

HemoCue 201 DM – DMS Software CD and HemoCue Glucose 201 DM RT System
Model: 131050, 131071
SW-Version: 3.0

IVD: Glucose monitoring system IVD, point-of-care

EN-1

Vk_20190910_15

17.09.2019

W.O.M. World of Medicine GmbH

Aquilex Fluid Control System
Model: AQL-100CBS
S/N: See FSN

MD: Hysteroscopic irrigation/insufflation system

DE-1
FR-1
EN-1

Vk_20190912_14

17.09.2019

Datex Ohmeda

Aespire
Model: 7100/100/Protiva/Carestation
SW-Version: 1.x

Aestiva
Model: 7100, 7900, MRI
SW-Version: 1.x, 2.x, 3.x

MD: Neonatal/adult intensive-care ventilator

MD: Neonatal/adult intensive-care ventilator

DE-1
FR-1
IT-1

Vk_20190910_17

03.09.2019 

(Updated 17.09.2019)

Pivotal Health Solutions

Epidural Positioning Device
Model: EPD Package 2

MD: Positioning aid

FR-1
EN-1

Vk_20190828_06

16.09.2019

CeMed GmbH

OP-Sets
Model: 76065

MD: Nierenschalen aus Faserformmaterial

DE-1

Vk_20190910_12

16.09.2019

Omni-Pac Ekco GmbH

MediTainer
Model: all
Lot: all

MediBowl
Model: all
Lot: all

MediDuo
Model: all
Lot: all

MD: Bowl

MD: Sheet, examination table

MD: Bowl

DE-1
FR-1
EN-1

Vk_20190910_11

16.09.2019

Philips Goldway (Shenzhen) Industrial Inc.

Efficia DFM 100
Model: 866199
S/N: UAL86000260

MD: Rechargeable professional automated external defibrillator

DE-1
FR-1
IT-1
EN-1

Vk_20190902_08

24.07.2019 

(Updated 16.09.2019)

Radiometer Medical ApS

AQURE system
Model: 933-599
SW-Version: Below Version 2.3.5 (i.e. 2.3.5. not included)

IVD: Medical equipment clinical data interfacing software

DE-1
DE-2
FR-1
FR-2
IT-1
IT-2
EN-1
EN-2

Vk_20190719_06

26.06.2019 

(Updated 16.09.2019)

Roche Diagnostics GmbH

MYO2 (Tina-quant Myoglobin Gen.2)
Model: 04580010190
Lot: see FSN

IVD: Myoglobin IVD, kit, chemiluminescent immunoassay

EN-1
EN-2
EN-3

Vk_20190621_05

13.09.2019

DiaMed GmbH

DC Screening II
Model: 004831, 004836, 004837
Lot: 50560 94 01, 50560 94 02, 50560 94 03

IVD: Polyspecific antihuman globulin/complement IVD, antibody, agglutination

EN-1

Vk_20190911_05

13.09.2019

Medset Medizintechnik GmbH

Patientenkabel, EKG Verstärkers BT-12
Model: AAZ135512-03

MD: Cable/lead, ECG

DE-1

Vk_20190906_04

13.09.2019 

(Updated 13.09.2019)

DiaSys Diagnostic Systems GmbH

CRP FS
Model: 1 7002..
Lot: 24753, 25005

IVD: C-Reactive Protein IC RT/POC => 12.70.11.01

DE-1
EN-1

Vk_20190903_05

11.09.2019

EIZO Corporation

RadiForce
Model: GX560, RX360
S/N: GX560 (serial numbers: 20001*** – 22874***), RX360 (serial numbers: 20001*** – 28451***)

MD: Image display monitor, colour

DE-1
FR-1
IT-1

Vk_20190903_04

10.09.2019

Gentherm Medical, LLC (formerly Cincinnati Sub-Zero)

Norm-O-Temp
Model: 111Z; 111W

MD: Circulating-fluid whole-body heating/cooling system control unit

DE-1
FR-1
IT-1

Vk_20190909_11

10.09.2019

Siemens Healthcare Diagnostics Inc

Atellica 1500 Automated Urine Sediment Analyzer
Model: SMN 11065004
SW-Version: V4.0.200 and V4.0. 220

Atellica UAS 800 Analyzer
Model: SMN 11065004
SW-Version: V4.0.200 and V4.0. 220

IVD: Urine analyser IVD, laboratory, automated

IVD: Urine analyser IVD, laboratory, automated

FR-1

Vk_20190904_13

02.04.2019 

(Updated 10.09.2019)

Datex-Ohmeda Inc., Ohmeda Medical a division of Datex-Ohmeda

Panda iRes Warmer
S/N: See FSN

Giraffe Warmer
S/N: See FSN

MD: Infant warmer

MD: Infant warmer

DE-1
DE-2
FR-1
FR-2
IT-1
IT-2
EN-2

Vk_20190401_22

09.09.2019

Tem Innovations GmbH

EXTEM
Model: 000503-05
Lot: 42255701

IVD: Other Other Haemostasis Reagents

DE-1
EN-1

Vk_20190830_16

09.09.2019

Motekforce Link B.V.

Body Weight Support (BWS) Light
Model: RB011
Lot: see FSN

MD: Treadmill/elliptical gait rehabilitation system, automated-guidance

DE-1
DE-2
FR-2
EN-1
EN-2

Vk_20190829_01

03.09.2019 

(Updated 09.09.2019)

Olympus Medical Systems Corp.

SINGLE USE SUCTION VALVE
Model: MAJ-209, 028978
Lot: 88H, 89H, 8XH, 8YH, 8ZH, 91H

MD: Endoscopic procedure air/water valve, single-use

DE-1
FR-1
IT-1
EN-1

Vk_20190828_17

06.09.2019

munevo GmbH

munevo Drive
S/N: MD18V10001-MD18V10030

MD: Wheelchair steering/control unit

DE-1
FR-1
IT-1
EN-1

Vk_20190826_16

03.09.2019 

(Updated 05.09.2019)

Mölnlycke Health Care AB

Barrier Sets
Model: see fsn
Lot: see fsn

MD: General/plastic surgical procedure kit, non-medicated, single-use

DE-2
FR-2
IT-2
EN-1
EN-2

Vk_20190830_09

05.09.2019

Becton, Dickinson & Company

BD FACSLyric Flow Cytometer
Model: 651164; 651165; 654587; 659180; 663029
Lot: refer to FSN

IVD: Flow cytometry analyser IVD, automated

DE-1
FR-1
IT-1
EN-1

Vk_20190827_11

05.09.2019

Spiggle & Theis Medizintechnik GmbH

Panetti suction separator
Model: 10-808-12
Lot: 045/02-18

MD: Suction Tips, General-Purpose

DE-1
FR-1
IT-1
EN-1

Vk_20190822_14

27.08.2019 

(Updated 05.09.2019)

Limacorporate S.p.a.

Revision-LR stem
Model: see FSN
Lot: see FSN

Modulus-R stem
Model: see FSN
Lot: see FSN

Revision stem
Model: see FSN
Lot: see FSN

Modulus stem
Model: see FSN
Lot: see FSN

MD: Uncoated hip femur prosthesis, modular

MD: Uncoated hip femur prosthesis, modular

MD: Uncoated hip femur prosthesis, modular

MD: Uncoated hip femur prosthesis, modular

DE-1
FR-1
EN-1

Vk_20190821_01

05.09.2019

Howmedica Osteonics Corp

Triathlon
Model: 5541-A-201; 5541-A-202; 5542-A-201; 5542-A-202
Lot: See list attached in the FSN

MD: Knee arthroplasty wedge

DE-1
FR-1
IT-1

Vk_20190812_11

03.09.2019 

(Updated 04.09.2019)

Pajunk GmbH

SPROTTE Lumbal
Model: 331151-30C, 321151-30C, 321151-31C, 341151-30C, 321151-31A, 331151-31A, 331151-31B, 341151-31A
Lot: 1240 (2018-02-06) – 1313 (2019-07-30)

MD: Spinal needle, single-use

DE-1
FR-1
EN-1

Vk_20190902_03

03.09.2019

Roche Diagnostics GmbH

ALB2 (Albumin Gen.2)
Model: 05166861190 on cobas c 701/702
Lot: 33962301

BILT3 (Bilirubin Total Gen.3)
Model: 05795419190 on cobas c 701/702
Lot: 36133801

IVD: Albumin IVD, kit, spectrophotometry

IVD: Total bilirubin IVD, kit, spectrophotometry

DE-1
FR-1
EN-1

Vk_20190828_10

13.08.2019 

(Updated 03.09.2019)

Remel Europe Ltd.

Oxoid Staphytect plus
Model: DR0850M
Lot: 2462081

IVD: Staphylococcus kit

DE-1
FR-1
IT-1
EN-1

Vk_20190808_06

02.09.2019

Intersurgical Ltd

Economy – Anaesthetic Face Masks
Model: 1514000, 1515000, 1516000, 1517000
Lot: See FSN

MD: Anaesthesia face mask, single-use

DE-1
FR-1
EN-1

Vk_20190826_17

06.08.2019 

(Updated 30.08.2019)

Dedienne Santé

SYMBOL CUP DM: SCREW
Model: 3700502205879
Lot: 064271220A

MD: Orthopaedic bone screw, non-bioabsorbable, sterile

DE-1
FR-1
IT-1
EN-1

Vk_20190802_48

13.08.2018 

(Updated 29.08.2019)

Beckman Coulter, Inc.

UniCel DxH 900 Coulter Cellular Analysis System
S/N: All
SW-Version: all

UniCel DxH 600 Coulter Cellular Analysis System
S/N: All
SW-Version: all

UniCel DxH 800 Coulter Cellular Analysis System
S/N: All
SW-Version: all

IVD: Haematological cell analyser IVD, automated

IVD: Haematological cell analyser IVD, automated

IVD: Haematological cell analyser IVD, automated

DE-1
DE-2
DE-3
FR-1
FR-2
FR-2_2
FR-3
EN-1
EN-2
EN-3

Vk_20180802_25

28.08.2019

Vascular Solutions Inc.

TrapLiner Catheter
Model: 5567
Lot: 641224

MD: Vascular guide-catheter, single-use

DE-1
FR-1
IT-1
EN-1

Vk_20190822_13

28.08.2019

Siemens Healthcare Diagnostics Inc

Atellica CH 930 Analyzer
Model: 11067000
SW-Version: Software versions 1.19.2 and below

IVD: Chemiluminescent immunoassay analyser IVD, automated

EN-1

Vk_20190822_09

28.08.2019

Siemens Healthcare Diagnostics Inc

Atellica IM anti-CCP IgG (aCCP) assay
Model: 10732998
Lot: All Lots
SW-Version: Version 1.0

Atellica IM Pregnancy-Associated Plasma Protein-A assay
Model: 10733019, 10733020
Lot: All Lots
SW-Version: Version 1.0

IVD: Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassay

IVD: Pregnancy-associated plasma protein A (PAPP-A) IVD, kit, chemiluminescent immunoassay

EN-1

Vk_20190822_08

28.08.2019

Spierings Orthopaedics B.V.

REX Cement Stop
Model: REX-0709-9, REX-0709-10, REX-0709-11.5, REX-0709-13.5m REX-0709-16
Lot: 011801; 021805, 101703, 111801; 111801; 111801; 011904

MD: Gelatin orthopaedic cement restrictor

DE-1
FR-1
IT-1
EN-1

Vk_20190822_07

28.08.2019

Cardiac Pacemakers, Inc, (Boston Scientific Corporation)

Emblem S-ICD
Model: A209

Emblem MRI S-ICD
Model: A219

AIMD: Single-chamber implantable defibrillator

AIMD: Single-chamber implantable defibrillator

DE-1
FR-1
IT-1
EN-1

Vk_20190821_15

28.08.2019

Caesarea Medical Electronics Ltd

T34 TM Ambulatory Syringe Pump
S/N: all

MD: Syringe pump

DE-1
FR-1
EN-1

Vk_20190820_06

28.08.2019

Medtronic (Schweiz) AG

Micra (leadless pacemaker)
Model: MC1VR01
Lot: all
S/N: all

AIMD: Intracardiac pacemaker

DE-1
FR-1
IT-1
EN-1

Vk_20190814_03

13.08.2019 

(Updated 28.08.2019)

Biomatrica, Inc.

LBgard Blood Collection Tube
Model: CE-71001-002
Lot: A1710353, A18043A5, A1807398, A1811357, A190236R, A190337V, A190435Y, A1905385

IVD: Blood Collection Tube

DE-2
FR-2
IT-2
EN-1
EN-2

Vk_20190809_02

27.08.2019

Thoratec Switzerland GmbH

CentriMag Motor
Model: 201-10002
S/N: Certain Serial Numbers between L05333-0001 and L06608-0024 A list of affected serial numbers per country is attached to this report.

MD: Cardiopulmonary bypass system centrifugal pump drive unit

DE-1
FR-1
IT-1
EN-1

Vk_20190822_05

26.08.2019

Intersurgical Ltd

BVM RESUSCITATOR ADULT 1.5L BAG SIZE 3 & 5 MASK
Model: 36086
Lot: 31859958, 31954342, 31950173, 31955117

MD: Anaesthesia face mask, single-use

DE-1

Vk_20190813_11

07.08.2018 

(Updated 23.08.2019)

Covidien LLC

BIS Vista and BIS View Monitoring Systems
Model: 186-1046, 186-1049, 186-1002-RFB, 186-1001-RFB, 186-0215, 185-0151, 186-1015,186-1048
Lot: All

MD: Anaesthesia depth monitor

DE-1
FR-1
IT-1
EN-2

Vk_20180806_09

22.08.2019

DiaMed GmbH

IH-1000
Model: 001000
Lot: NA
S/N: NA
SW-Version: 04.07.03

IVD: Immunohaematology/blood bank analyser IVD, automated

EN-1

Vk_20190814_10

21.08.2019

Roche Diagnostics GmbH

STFR (Tina-quant Soluble Transferrin Receptor)
Model: 20763454122 (STFR on cobas c 311, cobas c 501/502, COBAS INTEGRA 400 plus), 05950821190 (STFR on cobas c 701/702)

IVD: Transferrin IVD, kit, nephelometry/turbidimetry

EN-1

Vk_20190816_02

14.08.2019 

(Updated 21.08.2019)

ArjoHuntleigh AB

Concerto & Basic Shower Trolley
Model: BAB1000-01, BAB1000CON6102, BAB1007-01, BAB1101-01, BAB1102-01, BAB1103-01, BAB1107-01, BAB2000-01, BAB2101-01, BAB2102-01, BAB3000-01, BAB3101-01, BAB3107-01, BAB5000-01
S/N: see FSN

MD: Bathing/changing table, mobile

DE-1
FR-1
EN-1

Vk_20190812_03

20.08.2019

Baxter Healthcare SA

PrisMax Hemodialysis Machine
Model: 955558
S/N: See Affected Product Table
SW-Version: N/A

MD: Haemodialysis system, institutional

DE-1
FR-1
EN-1

Vk_20190814_06

20.08.2019

Flowonix Medical

Prometra Programmable Pump
Model: 91827
Lot: All
S/N: All
SW-Version: 0026

Prometra II Pump
Model: 93827
Lot: All
S/N: All
SW-Version: 0026

Prometra Programmer
Model: 91828
Lot: all
S/N: all
SW-Version: 1.03, 1.06, 1.06.1

AIMD: Implantable intrathecal infusion pump, programmable

AIMD: Implantable intrathecal infusion pump, programmable

MD: Infusion pump programmer

EN-1

Vk_20190814_04

18.03.2019 

(Updated 20.08.2019)

Medtronic Inc.

Pulmonary Vein Catheter GOLD (PVAC GOLD)
Model: 990078
Lot: All

MD: Cardiac mapping/radio-frequency ablation catheter, single-use

DE-1.0
FR-1.0
EN-1.0

Vk_20190306_05

19.08.2019

Zimmer GmbH

Sidus Stem-Free Shoulder Humeral Head 50-18
Lot: 2941696

MD: Total shoulder prosthesis

DE-1
EN-1

Vk_20190819_05

19.08.2019

Natus Neurology Incorporated

Surface Temperature Probe
Model: 268-411800

MD: General-purpose patient temperature probe, reusable

DE-1
FR-1
EN-1

Vk_20190805_29

16.08.2019

Medline International France SAS

Sterile Absorbent Cotton O.R Towels

MD: Surgical towel

DE-1
FR-1

Vk_20190808_13

16.08.2019

Siemens Healthcare GmbH

Mammomat Revelation
Model: 11343300

MD: Stationary mammographic x-ray system, digital

DE-1
FR-1

Vk_20190807_06

07.08.2019 

(Updated 16.08.2019)

Siemens Healthcare GmbH

SOMATOM
Model: 04056869051314, 04056869051291, 04056869151564, 04056869151571

MD: Full-body CT system

DE-1
DE-2

Vk_20190802_07

15.08.2019

Nihon Kohden Corp.

Life Scope G5
Model: CSM-1501, CSM-1502; Catalog: CU-151RK, CU-152RK
SW-Version: below 02-15

Life Scope G7
Model: CSM-1701, CSM-1702; Catalog: CU-171RK, CU-172RK
SW-Version: below 02-15

MD: Single-patient physiologic monitoring system

MD: Single-patient physiologic monitoring system

DE-1
EN-1

Vk_20190814_07

15.08.2019

Medineering GmbH

Surgical Base System
Model: 1.3; 2010-01, 2010-02, 2010-03
S/N: see fsn

MD: Positioning Aids

DE-1
EN-1

Vk_20190809_20

15.08.2019

HYPHEN BioMed SAS

ZYMUTESTTM Anti-VIII MonoStrip IgG

ZYMUTEST HIA MonoStrip lgG

ZYMUTEST HIA MonoStrip lgGAM

IVD: Coagulation factor VIII IVD, kit, enzyme immunoassay (EIA)

IVD: Total immunoglobulin G (IgG total) IVD, kit, enzyme immunoassay (EIA)

IVD: Polyvalent human immunoglobulin antibody IVD, antibody

FR-1
EN-1

Vk_20190808_15

14.08.2019

The Binding Site Group Limited

VaccZyme Human Anti-Haemophilus Influenzae type b
Model: MK016
Lot: 413170, 435314

IVD: Haemophilus influenzae culture isolate antigen IVD, antibody

EN-1

Vk_20190813_01

14.08.2019

Thermo Fisher Scientific Microbiology Basingstoke

Thermoscientific Oxoid Meropenem 32 M.I.C.E.
Model: MA0121D & F
Lot: 2481054, 2475332, 2457512, 2434303, 2434301, 2431420, 2430549, 2430548, 2430550, 2430546, 2430547, 2430544, 2430545

IVD: Antibacterial minimum inhibitory concentration (MIC) IVD

EN-1

Vk_20190808_17

14.08.2019

UROMED Kurt Drews GmbH

UROMED KATHETERISIERUNGSBESTECK
Model: 1560

MD: Urethral catheterization support kit, urinary drainage

DE-1

Vk_20190808_16

14.08.2019

Roche Diagnostics GmbH

AssayTip/AssayCup tray on cobas e 801
Model: 05694302001
Lot: see FSN

IVD: Chemiluminescent immunoassay analyser IVD, automated

EN-1

Vk_20190808_03

14.08.2019

Angiokard Medizintechnik GmbH

Uro-Set
Model: HM9760.1
Lot: 165625-000, 165626-000, 166455-000, 172059-000, 172198-000, 174153-000, 178851-000, 180435-000, 182952-000, 184227-000, 188000-000, 192005-000, 193192-000

MD: Sets mit Papp-Nierenschale

DE-1

Vk_20190807_16

14.08.2019

Siemens Healthcare Diagnostics Inc

Atellica CH 930 Analyzer
Model: SMN 11067000
SW-Version: V1.19.2 and below.

IVD: Chemiluminescent immunoassay analyser IVD, automated

EN-1

Vk_20190807_09

13.08.2019 

(Updated 14.08.2019)

EUROSETS S.R.L.

TRILLY Oxygenator
Model: EU5057, AG5032, AG5033, AG5061, AG5232
Lot: See FSN

MD: Membrane oxygenator

DE-1
FR-1
IT-1
EN-1

Vk_20190806_10

08.08.2019 

(Updated 14.08.2019)

Rocket Medical

Rocket KCH Fetal Bladder Drain
Model: R57405
Lot: all

MD: Suprapubic drainage catheter

DE-1
FR-1
IT-1
EN-1

Vk_20190802_55

18.06.2019 

(Updated 14.08.2019)

Natus Medical Denmark, GN Otometrics A/S

Chartr EP 200
Model: See FSN
S/N: All

MD: Auditory stimulator

DE-1
DE-2
FR-1
FR-2
IT-1
IT-2
EN-1
EN-2

Vk_20190617_05

07.08.2019 

(Updated 13.08.2019)

MAQUET Cardiopulmonary GmbH

Heater Unit HU35
Model: 70107.2162; 70107.2163;70107.2162; 70107.2163
S/N: Serial number range and material number of potentially affected products produced within the timeframe September, 2017 until October, 2018 (details see Annex I)
SW-Version: 1.02

MD: Cardiopulmonary bypass system heat exchanger

DE-1
FR-1
EN-1

Vk_20190802_58

12.08.2019

HIGH TECHNOLOGY PRODUCTS S.L.U

Cooltech
Model: 521007
Lot: 521007UC-01462; 521007UC-01703

MD: Thermal skin treatment system

DE-1
FR-1
IT-1
EN-1

Vk_20190802_20

07.08.2019 

(Updated 12.08.2019)

MESI

Automated Ankle-Brachial Index measuring device
Model: ABPIMDD

MD: Noninvasive ankle brachial pressure index measurement unit

DE-1
FR-1
IT-1
EN-1

Vk_20190729_07

23.07.2019 

(Updated 12.08.2019)

Uptake Medical Technology, Inc.

InterVapor System
Model: UM-GEN-100, UM-CTH-100, UM-IP3-100
SW-Version: UM-IP3-100: 9.1

MD: thermal vapor lung treatment system

DE-1
DE-2
FR-1
FR-2
IT-1
IT-2
EN-1

Vk_20190717_09

25.07.2019 

(Updated 12.08.2019)

Novacor SAS

R.TEST 4
Model: RTE-0001-03
S/N: NRT11000113 onwards

MD: Electrocardiograph, professional, single-channel

DE-1
FR-1
IT-1
EN-1

Vk_20190716_17

07.06.2019 

(Updated 12.08.2019)

Teleflex Medical

Sheridan Close Fitting Endotracheal Tube

Sheridan Endotracheal Tube

Sheridan HVT Endotracheal Tube

Sheridan HVT EZ-Endo Endotracheal Tube

Sheridan Preformed Endotracheal Tube

Sheridan Uncuffed Endotracheal Tube

MD: Basic endotracheal tube, single-use

MD: Basic endotracheal tube, single-use

MD: Basic endotracheal tube, single-use

MD: Basic endotracheal tube, single-use

MD: Basic endotracheal tube, single-use

MD: Basic endotracheal tube, single-use

DE-1
DE-2
FR-1
FR-2
IT-1
IT-2
EN-1
EN-2

Vk_20190528_15

30.04.2019 

(Updated 12.08.2019)

Edwards Lifesciences LLC

EV1000 Clinical Platform System
Model: EV1000A, EV1000NI
S/N: ALL

MD: Patient monitoring system

DE-1
DE-2
FR-1
FR-2
IT-1
IT-2
EN-1
EN-2

Vk_20190424_07

06.08.2019 

(Updated 09.08.2019)

Quantel Médical

EasyRet
Model: PABX0013
SW-Version: All

MD: Ophthalmic laser

DE-1
FR-1
IT-1
EN-1

Vk_20190805_28

07.08.2019 

(Updated 09.08.2019)

Siemens Healthcare GmbH; Business Area Advanced Therapies

Artis Zee

Artis Q

MD: Stationary angiographic x-ray system, digital

MD: Stationary angiographic x-ray system, digital

FR-1
EN-1

Vk_20190805_19

09.08.2019

Nobel Biocare AB

Temporary Abutment Non-Engaging CC RP
Model: 36662
Lot: 13078005

Temporary Abutment Engaging CC RP
Model: 36664
Lot: 13077622

Esthetic Abutment CC RP
Model: 36669
Lot: 13077560

Snappy Abutment 5.5 CC RP
Model: 36683
Lot: 13077700

Universal Base CC RP
Model: 38214
Lot: 13076822

Temporary Snap Abut Eng CC RP
Model: 38761
Lot: 13077550, 13077551

MD: Dental implant suprastructure, temporary, preformed, single-use

MD: Dental implant suprastructure, temporary, preformed, single-use

MD: Dental implant suprastructure, permanent, preformed

MD: Dental implant suprastructure, permanent, preformed

MD: Dental implant suprastructure, permanent, preformed

MD: Dental implant suprastructure, temporary, preformed, single-use

DE-1
EN-1

Vk_20190731_02

08.08.2019

Ortho Clinical Diagnostics

ORTHO BioVue System ABD Confirmation Cassette
Model: 707135
Lot: ACC054H

IVD: ABO/Rh(D) multiple blood grouping IVD, kit, agglutination

EN-1

Vk_20190805_25

07.08.2019

Philips Medical Systems Nederland BV

Philips Azurion system
Model: 722063, 722064, 722067, 722068, 722078, 722079
SW-Version: Release 1.2

MD: Stationary general-purpose fluoroscopic x-ray system, analogue

DE-1
EN-1

Vk_20190802_64

07.08.2019

Philips Medical Systems Nederland BV

Philips Azurion system
Model: 722063, 722064, 722067, 722068, 722078, 722079
SW-Version: Release 1.2

MD: Stationary general-purpose fluoroscopic x-ray system, analogue

DE-1
EN-1

Vk_20190802_61

07.08.2019

bioMerieux Inc

VIDAS FT4
Model: 30459
Lot: 1007146010, 1006987180, 1007008470, 1006896240, 1006878320, 1006942720

IVD: Free thyroxine (FT4) IVD, kit, enzyme immunoassay (EIA)

EN-1

Vk_20190802_57

07.08.2019

The Binding Site Group Limited

Optilite IgM Kit
Lot: 420256

IVD: Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry

EN-1

Vk_20190802_21

06.08.2019 

(Updated 07.08.2019)

B. Braun Melsungen AG

Serofine
Model: 16441MS
Lot: 18E28G8712, 18G01G8711, 18G02G8711, 18G02G8712

MD: needle

DE-1
FR-1
IT-1

Vk_20190731_12

07.08.2019

bioMerieux Inc

A7 Mycoplasma Agar (MYCO)
Model: 43003
Lot: 1007415500

IVD: Mycoplasma agar culture medium IVD

EN-1

Vk_20190731_11

07.08.2019

Amplitude S.A.S.

AMPLIVISION – Fixation K-wire Ø4
Model: 2-0208700; 2-0208702; 2-0223700
Lot: All the batches numbers

MD: Orthopaedic prosthesis implantation instrument, reusable

FR-1
EN-1

Vk_20190724_11

07.08.2019

Electromedical Products International, Inc.

Alpha Conducting Solution
Model: ACS, ACSR (Refill);3310-15 (ACS 15 ml) and 3310-25 (ACSR Refill 250 ml)
Lot: ACS : 081914-15 ; 111715-15 ; 070116-15 ; 020117-15 ; 080117-15 ; 010118-15 ; 041618-15 ; 041618A-15 ; 071618-15 ; 122018-15 ; ACSR : 032014-25 ; 060515-25 ; 101615-25 ; 011716-25 ; 021117-25 ; 080117-25 ; 010118A-25 ; 041618-25 ; 071618-25 ; 102018A-25

MD: Psychiatric-therapy face/head electrical stimulation system

DE-1
FR-1
IT-1
EN-1

Vk_20190709_03

24.06.2019 

(Updated 07.08.2019)

Siemens Healthcare Diagnostics Inc

Stratus CS Acute Care cTnI TestPak
Model: SMN #10445071
Lot: see FSN

IVD: Troponin kit

FR-1
FR-2
EN-1
EN-2

Vk_20190612_14

30.07.2019 

(Updated 06.08.2019)

IMACTIS SAS

IMACTIS – Single Use Navigation Kit
Model: I10100
Lot: 17110001, 18010001, 18010002, 18040001, 18060001, 18070001, 18110001, 18110002, 18120001, 19010002, 19020001, 19020002, 19030001, 19040001, 19060001, 19060002

MD: Robotic surgical navigation system

DE-1
FR-1
IT-1
EN-1

Vk_20190730_11

30.07.2019 

(Updated 06.08.2019)

Intersurgical Ltd

DOUBLE SWIVEL ELBOW 15M
Model: 1898000
Lot: 2180406, 2180731, 2181507, 2181793, 2190139, 2190292, 2191327

Flexible Double Swivel Catheter Mound 22F
Model: 3505000
Lot: 2183450, 2190043, 2191286

Superset Double Swivel Catheter Mount 22F
Model: 3521000
Lot: 2180327, 2180366, 2180532, 2180860, 2181350, 2181503, 2181753, 2182119, 2182182, 2182209, 2182536, 2182852, 2183480, 2190190, 2190617, 2190735, 2191410

MD: Tube/mask breathing circuit connector, single-use, non-sterile

MD: Catheter mount, single-use

MD: Catheter mount, single-use

DE-1
FR-1
IT-1
EN-1

Vk_20190729_05

06.08.2019

Diaspective Vision GmbH

Tivita Camera
Lot: see FSN

MD: hyperspectral camera

DE-1
EN-1

Vk_20190726_07

06.08.2019

MEDOS Medizintechnik AG

Various kits containing DP3 pumpheads
Lot: see product list

MD: Cardiopulmonary bypass system centrifugal pump

DE-1
FR-1
IT-1
EN-product list

Vk_20190712_11

25.06.2019 

(Updated 05.08.2019)

Abbott

Ellipse VR/DR
Model: CD2377-36QC, CD2377-36C, CD1377-36QC, CD1377-36C
S/N: See attached List of affected serial numbers

AIMD: Implant, cardiac pacemaker

EN-2

Vk_20190621_16

02.08.2019

Medisoft

FeNO+
Model: FE-00-01
Lot: FE-00-01

MD: Nitrogen monoxide analyser

DE-1
FR-1
EN-1

Vk_20190724_10

31.07.2019

Siemens Healthcare Diagnostics Inc.

ADVIA Centaur Folate, ADVIA Centaur XP Folate, ADVIA Centaur XPT Folate
Model: See FSN
Lot: See FSN

IVD: Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay

EN-1

Vk_20190729_11

31.07.2019

GE OEC Medical Systems GmbH

OEC Fluorostar, OEC Fluorostar Compact, OEC Fluorostar Compact D
S/N: see FSN

MD: Mobile general-purpose fluoroscopic x-ray system, digital

DE-1
FR-1
IT-1
EN-1

Vk_20190725_08

31.07.2019

Siemens Healthcare Diagnostics Inc

Dimension Ferritin Flex reagent cartridge
Model: RF440; SMN 10444946
Lot: EA9227
S/N: N/A
SW-Version: N/A

IVD: Ferritin IVD, kit, enzyme immunoassay (EIA)

EN-1

Vk_20190725_07

31.07.2019

AIR LIQUIDE MEDICAL SYSTEMS

MONNAL T60
S/N: all

MD: Transport electric ventilator

DE-2
FR-2
IT-2
EN-1 (CH not affected)
EN-2

Vk_20190404_12

30.07.2019

Zimmer GmbH

Allofit-S Alloclassic, shell with polar screw plug, uncemented
Model: 4265; 4266
Lot: 2984922; 298495 8; 2984959;
S/N: N/A
SW-Version: N/A

MD: Metallic acetabulum prosthesis

DE-1
EN-1

Vk_20190730_04

30.07.2019

AIR LIQUIDE MEDICAL SYSTEMS

MONNAL T60
Model: KA010000, KA017114, KA017115

Monnal T60 JP
Model: KA013700

MONNAL T75
Model: KB022600,KB040001

MONNAL T75 JP
Model: KB032100

MONNAL T75 CO2
Model: KB033600, KB040003

MONNAL T50
Model: KC027500, KC072219, KC07220

MONNAL T50 JP
Model: KC039100

MONNAL T50 DE
Model: KC037600

MONNAL T40
Model: KC027600

MONNAL T40 DE
Model: KC037500

MD: Transport electric ventilator

MD: Transport electric ventilator

MD: General-purpose intensive-care ventilator

MD: General-purpose intensive-care ventilator

MD: General-purpose intensive-care ventilator

MD: Neonatal/adult intensive-care ventilator

MD: Neonatal/adult intensive-care ventilator

MD: Neonatal/adult intensive-care ventilator

MD: Ventilator, home-use

MD: Ventilator, home-use

DE-1
FR-1
IT-1
EN-1

Vk_20190729_13

30.07.2019

GE Medical Systems Information Technologies, Inc.

MAC VU360 Resting ECG Analysis System
Model: 2030360-001
SW-Version: V1.01, V1.01 SP01, V1.01 SP02

MD: Electrocardiograph, professional, multichannel

DE-1
FR-1
IT-1
EN-1

Vk_20190729_01

30.07.2019

Occlutech GmbH

Occlutech Delivery Set
Model: v01; 51DS010
Lot: S18151
S/N: N/A
SW-Version: N/A

MD: Cardiac occluder delivery kit

DE-1
FR-1
IT-1
EN-1

Vk_20190725_02

30.07.2019

Siemens Healthcare Diagnostics Products Limited

IMMULITE/IMMULITE 1000 Progesterone
Model: LKPW1
Lot: Kit lots 0259 and above

IMMULITE 2000/IMMULITE 2000 XPi Progesterone
Model: L2KPW2, L2KPW6
Lot: Kit lots 510 and above

IVD: Progesterone IVD, kit, chemiluminescent immunoassay

IVD: Progesterone IVD, kit, chemiluminescent immunoassay

EN-1

Vk_20190723_14

26.07.2019 

(Updated 30.07.2019)

CooperSurgical Inc.

TransWarmer Warming Infant Transport Mattress
Model: 20421
Lot: See FSN

MD: Reactive-gel heating pad

DE-1
FR-1
IT-1
EN-1

Vk_20190722_10

16.07.2019 

(Updated 30.07.2019)

Leonhard Lang GmbH

GS defibrillation electrodes
Model: GS CORPATCH EASY PRE-CONNECTED; 05120.1
Lot: 190611-4017
SW-Version: n.a.

MD: Electrodes, Cardiac, External Defibrillator

DE-1
FR-1
IT-1
EN-1

Vk_20190711_06

26.06.2018 

(Updated 30.07.2019)

Boston Scientific Corporation

Maestro 4000 Cardiac Ablation System
Model: Footswitch: M004218500, M00421850D0, M00421850H0, M00421850R0, M00421850Z0; Pump to Generator Cable: M004315000; Controller: M00440000, M0044000D0, M0044000H0, M0044000R0, M0044000Z0
Lot: Device Manufacturing date Starting from 21st May 2014
S/N: All
SW-Version: Firmware Update version 5.23

MD: Generator, lesion, radiofrequency

DE-1
DE-2
FR-1
FR-2
IT-1
IT-2
EN-1
EN-2

Vk_20180620_16

29.07.2019

Microtek Medical Malta Ltd.

Intraoperative Probe Cover with Long Surgi-Tip
Model: PC3688EU
Lot: 1611753V, 1612016V, 1612154V, 1612332V, 1712400V, 1712645V, 1712752V, 1712940V, 1713076V, 1713163V, 1713165V, 1813407V, 1813523V, 1813667V, 1813675V, 1813760V, 1813877V, 1813943V, 1814226V, 1914553V, 1914677V
S/N: N/A

MD: Intraoperative ultrasound imaging transducer cover

DE-1
FR-1
IT-1
EN-1

Vk_20190722_07

08.05.2019 

(Updated 26.07.2019)

Abbott Laboratories

ARCHITECT c4000 / c8000 / c16000 Mixer
Model: 09D59-01, -02, -03 (02P24, 01G06, 03L77 ARCHITECT c Analyzer)
S/N: All Serial numbers

IVD: Multichannel clinical chemistry analyser IVD, laboratory, automated

DE-1
FR-1
IT-1
EN-1

Vk_20190503_13

25.04.2018 

(Updated 26.07.2019)

Roche Diagnostics GmbH

Combur-Test UX, Chemstrip 10 A
Model: see FSN

Urisys 1100
Model: see FSN

IVD: Urine rapid test device, multiple-constituent

IVD: Urine analyser IVD, laboratory, automated

DE-1
DE-2
FR-1
FR-2
IT-1
IT-2
EN-1
EN-2

Vk_20180420_08

25.07.2019

Randox Laboratories Ltd

Calibration Serum Level 3
Model: CAL2351
Lot: see FSN

Bovine Chemistry Assayed, Liquid Assayed Chemistry Control Premium, Assayed Chemistry Control Premium Plus
Model: see FSN

IVD: Multiple clinical chemistry analyte IVD, calibrator

IVD: Controls, Standards and Calibrators – Clinical Chemistry

EN-1

Vk_20190722_02

25.07.2019

Philips Medical Systems DMC GmbH

DigitalDiagnost
Model: 712031, 712032, 712033;NA
Lot: NA
SW-Version: 4.2.x

MD: Stationary basic diagnostic x-ray system, digital

DE-1
EN-1

Vk_20190718_25

18.07.2019 

(Updated 25.07.2019)

Roche Diagnostics GmbH

ONLINE TDM Vancomycin Gen.3 (VANC3)
Model: 06779336190, 06779344190, 06781632190, 08445605190, 08058849190

IVD: Vancomycin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry

DE-1
FR-1
IT-1
EN-1

Vk_20190715_14

24.07.2019

Ortho-Clinical Diagnostics, Inc

ORTHO VISION Max Analyzer
Model: 6904578
SW-Version: 5.12.3 and 5.12.4

ORTHO VISION Analyser
Model: 6904579
SW-Version: 5.12.3 and 5.12.4

IVD: Blood group/antibody screening analyser IVD, automated

IVD: Blood group/antibody screening analyser IVD, automated

EN-1

Vk_20190722_03

24.07.2019

Becton, Dickinson & Company

BD Max Reagents
Model: see FSN
Lot: see FSN

IVD: Reagents for DNA and/or RNA amplification and/or detection: bacteria and/or virus

EN-1

Vk_20190719_12

24.07.2019

Hitachi High Technologies Corporation (HHT)

cobas analyzers, modules, analytical units
Model: see FSN

IVD: INSTRUMENTS , CONSUMABLES, SPARE PARTS, SOFTWARE, SERVICE

EN-1

Vk_20190719_02

24.07.2019

Phadia AB

Phadia 1000
Model: 12-3800-01
S/N: All serial numbers

IVD: Fluorescent immunoassay analyser IVD, laboratory, automated

EN-1

Vk_20190717_11

24.07.2019

SENTINEL CH SpA

Alinity c Lithium Reagent Kit
Model: 08P5320
Lot: n/a

Lithium
Model: 8L25-30
Lot: n/a

IVD: Lithium therapeutic drug monitoring IVD, reagent

IVD: Lithium therapeutic drug monitoring IVD, reagent

EN-1 (Alinity)
EN-1 (Lithium)

Vk_20190716_35

23.07.2019 

(Updated 24.07.2019)

Bode Chemie GmbH

Mikrobac Virucidal Tissues
Model: 981531
Lot: all

MD: Medical device cleaning/disinfection wipe

DE-1
FR-1
IT-1

Vk_20190716_14

16.07.2019 

(Updated 24.07.2019)

Clinical Innovations LLC

Kiwi Complete Vacuum Delivery System
Model: VAC-6000MTE
Lot: 181144

MD: Foetal vacuum extraction system cup, reusable

DE-1
FR-1
EN-1

Vk_20190712_01

27.06.2019 

(Updated 24.07.2019)

Datascope Corp.

CARDIOSAVE Hybrid Intra-Aortic Balloon Pump
Model: 0998-00-0800-XX, 0998-UC-0800-XX, 0998-00-3013-XX, 0998-00-3023-XX;N/A
Lot: N/A
S/N: All Cardiosave serial numbers distributed March 6, 2012 to present All CS100 and CS300 serial numbers distributed March 24, 2003 to present
SW-Version: N/A

MD: Intra-aortic balloon pump

DE-1
FR-1
IT-1
EN-1

Vk_20190619_15

23.07.2019

Apollo Endosurgery Inc

BIB Intragastric Balloon System
Model: B-40800

Orbera365 Intragastric Balloon System
Model: B-50012

MD: Appetite-suppression gastric balloon

MD: Appetite-suppression gastric balloon

DE-1
FR-1
IT-1
EN-1

Vk_20190719_07

23.07.2019

Philips Healthcare

iCT

Ingenuity TF

Brilliance CT 64

Ingenuity CT

IQon Spectral CT

Vereos PET/CT

MD: PET/CT system

MD: PET/CT system

MD: Full-body CT system

MD: Full-body CT system

MD: Full-body CT system

MD: PET/CT system

DE-1
FR-1
IT-1
EN-1

Vk_20190718_22

23.07.2019

Medtronic Navigation Inc.

Visualase Cooled Laser Applicator System (VCLAS)
Model: 9735559, 97355560, 9735561
Lot: from 0211041602 through 0217695790

MD: General/multiple surgical diode laser system

EN-1

Vk_20190718_11

23.07.2019

seca gmbh & co. kg

seca 402 and seca 403
Model: 402, 403 4030000009
S/N: seca 402: 6002142000001 – 6002142001101; seca 403: 6002143000001 – 6002143001851

MD: Electromechanical device/system transport trolley

DE-1

Vk_20190717_12

23.07.2019

Mölnlycke Health Care AB

Exufiber Ag+ 2x45cm x 5 pcs
Model: 603400-00
Lot: 19028512

Exufiber Ag+ 5x5cm x 10 pcs
Model: 603401-00
Lot: 19028513

Exufiber Ag+ 10x10cm x 10 pcs
Model: 603402-00
Lot: 19028514

Exufiber Ag+ 15x15cm x 10 pcs
Model: 603403-00
Lot: 19028515

Exufiber Ag+ 4.5x10cm x 10 pcs
Model: 603404-00
Lot: 19028516

Exufiber Ag+ 4.5x20cm x 10 pcs
Model: 603405-00
Lot: 19049284

Exufiber Ag+ 4.5x30cm x 10 pcs
Model: 603406-00
Lot: 19039285

Exufiber Ag+ 20x30cm x 5 pcs
Model: 603407-00
Lot: 19028520, 19039286

MD: Exudate-absorbent dressing, hydrophilic-gel, antimicrobial, sterile

MD: Exudate-absorbent dressing, hydrophilic-gel, antimicrobial, sterile

MD: Exudate-absorbent dressing, hydrophilic-gel, antimicrobial, sterile

MD: Exudate-absorbent dressing, hydrophilic-gel, antimicrobial, sterile

MD: Exudate-absorbent dressing, hydrophilic-gel, antimicrobial, sterile

MD: Exudate-absorbent dressing, hydrophilic-gel, antimicrobial, sterile

MD: Exudate-absorbent dressing, hydrophilic-gel, antimicrobial, sterile

MD: Exudate-absorbent dressing, hydrophilic-gel, antimicrobial, sterile

EN-1

Vk_20190717_01

23.07.2019

Medical Intelligence Medizintechnik GmbH

HexaPOD evo RT System
Model: P10603-109, P10603-110 and P10603-111
Lot: N/A
S/N: N/A
SW-Version: iGUIDE 2.2.0, 2.2.1 & 2.2.2

MD: Tables, Radiotherapy

DE-1
FR-1
IT-1
EN-1

Vk_20190716_15

16.07.2019 

(Updated 19.07.2019)

Skulle Implants Corporation

Glace Screws 6 mm
Model: SIS-1201
Lot: All

MD: Craniofacial fixation plate kit, non-bioabsorbable

DE-1
FR-1
EN-1

Vk_20190710_05

19.07.2019

Qiagen GmbH

QIAsymphony SP
Model: 9001297
SW-Version: 5.0.3

IVD: SP Hardware + accessories + consumables + software

DE-1
FR-1
IT-1

Vk_20190709_12

25.06.2019 

(Updated 18.07.2019)

Stöpler Instrumenten & Apparaten B.V.

COCUNE – Feuchte Waschhandschuhe (parfümiert/unparfümiert)
Model: CCN 21-1001, CCN 21-1002, CCN 21-1004, CCN 21-1005
Lot: 00146, 00156, 02975, 02988, 03102, 03192, 03188, 03171, 03212, 03227, 03255, 00328, 03028, 03198, 00171

MD: wash gloves

DE-1
FR-1
IT-1
EN-2

Vk_20190624_17

17.07.2019

HERDEGEN SAS

Elbow crutch

MD: Elbow crutch

DE-1
FR-1
IT-1

Vk_20190708_03

16.07.2019

Edwards Lifesciences LLC

Edwards CENTERA Transcatheter Heart Valve System
Model: 9630TF20, 9630TF23, 9630TF26, 9630TF29
Lot: all
SW-Version: N/A

MD: Aortic transcatheter heart valve bioprosthesis, stent-like framework

DE-1
FR-1
IT-1
EN-1

Vk_20190712_12

16.07.2019

Johnson & Johnson AG

Neutrogena Light Therapy Acne Mask and Refill

MD: Red/blue light phototherapy unit

DE-1

Vk_20190711_10

16.07.2019

Zimmer Biomet Inc

Pulsavac Plus
Model: 00-5150-482-00, 00-5150-482-01
Lot: See FSN

Pulsavac Plus AC
Model: 00-5150-476-01, 00-5150-486-01
Lot: See FSN

MD: Disposable surgical irrigation/aspiration system

MD: Disposable surgical/orthopaedic lavage system, line-powered

DE-1
FR-1
IT-1
EN-1

Vk_20190709_06

16.07.2019

Smiths Medical ASD, Inc.

Deltec GRIPPER Needle
Model: see FSN
Lot: see FSN

MD: Mechanical pipette

DE-1
FR-1
IT-1
EN-1

Vk_20190709_05

10.07.2019 

(Updated 15.07.2019)

Roche Diagnostics GmbH

Elecsys Anti-CCP
Model: 05031656190, 05031656160, 07251670190
Lot: (368033, 376804, 389152), (358545, 368037, 376808, 389165), (368029, 376648, 388800)

IVD: Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, enzyme immunoassay (EIA)

DE-1
FR-1
EN-1

Vk_20190704_03

15.07.2019

Getinge Sterilization AB

Steam sterilizer
Model: GSS67H102E
Lot: BAA089235
S/N: 67H102E-CTOM
SW-Version: N/A

MD: Steam sterilizer

DE-1

Vk_20190703_35

14.11.2017 

(Updated 15.07.2019)

MULLIEZ FLORY

SECURIDRAP SELFIA
Model: blanc (reference fabriquant no 013293W02B0); bleu (reference fabriquant no 013293B02B0)
S/N: all

MD: safety bedding

FR-1
FR-2
FR-3
FR-4

Vk_20170728_06

12.07.2019

SAMSUNG MEDISON CO., LTD.

Ultrasonic Diagnostic Apparatus
Model: WS80A, HS70A

MD: General-purpose ultrasound imaging system

DE-1
FR-1
IT-1
EN-1

Vk_20190703_42

12.07.2019

Siemens Healthcare GmbH

SOMATOM Force, Drive, Confidence and more
Model: 8098027, 10430603, 10742326, 10431700, 10590000, 10590100, 10267000
SW-Version: syngo CT VB10A

MD: Full-body CT system

DE-1
FR-1

Vk_20190702_06

02.07.2019 

(Updated 12.07.2019)

Amplitude S.A.S.

Broach Handle
Model: 2-0103100
Lot: 1600624, 1800012, 1800013, 1800014, 1800015, 1800780, 1800781, 1800782, 1800783

MD: Orthopaedic prosthesis implantation instrument, reusable

DE-1
FR-1
EN-1

Vk_20190627_16

02.07.2019 

(Updated 12.07.2019)

Edwards Lifesciences LLC

IntraClude Intra-Aortic Occlusion Device
Model: ICF100
Lot: all

MD: Intravascular occluding balloon catheter, image-guided

DE-1
DE-2
FR-1
FR-2
IT-1
IT-2
EN-1
EN-2

Vk_20190627_02

12.07.2019 

(Updated 12.07.2019)

Spectrum Medical Ltd.

Quantum Pump Console
Model: all

MD: Cardiopulmonary bypass system roller pump

DE-1
FR-1
IT-1
EN-1

Vk_20190626_11

11.07.2019

Dermosciences France Sarl

Cosmo Peel Kit
Model: 12%, 15%, 18%, 20%

MD: Superficial skin exfoliant, professional

FR-1
EN-1

Vk_20190529_11

09.07.2019 

(Updated 10.07.2019)

Philips Healthcare

BrightView
Model: 882478
SW-Version: All

BrightView X
Model: 882480
SW-Version: All

BrightView XCT
Model: 882482, 882454 (BrightView X upgrade to XCT)
SW-Version: All

MD: Stationary gamma camera system

MD: Stationary gamma camera system

MD: PET/CT system

DE-1
FR-1
EN-1

Vk_20190703_39

10.07.2019

Möller-Wedel GmbH & Co. KG

FS 2-21, FS 2-25 and FS 3-45
Model: 615510, 615550, 615705
S/N: See FSN
SW-Version: 10.1.xx-11.3.xx

HS Hi-R NEO 900 /A /A NIR
Model: 657820, 657821, 657822
S/N: See FSN

MD: Microscope, operating

MD: Microscope, operating

DE-1
FR-1

Vk_20190625_20

09.07.2019

Biomet France

GTS Trunnion Rasp
Model: See FSN
Lot: See FSN

MD: Orthopaedic prosthesis implantation instrument, reusable

DE-1
FR-1
IT-1
EN-1

Vk_20190705_10

09.07.2019

GE Healthcare Austria GmbH & Co OG

RIC5-9-D, RIC5-9A-RS
Model: 198026KR7, 220616KR7, 226914KR0, 205375KR9

MD: Rectal/vaginal ultrasound imaging transducer

DE-1
FR-1
IT-1

Vk_20190705_07

09.07.2019

Elekta Inc.

Monaco RTP System
Model: N/A;N/A
Lot: N/A
S/N: Version 5.10 and 5.11
SW-Version: Version 5.10 and 5.11

MD: Radiation therapy software

DE-1
FR-1
IT-1
EN-1

Vk_20190704_17

09.07.2019

bioMerieux Inc

VIKIA Malaria Ag Pf/Pan
Model: 412499
Lot: 1006664060
S/N: N/A
SW-Version: N/A

IVD: Multiple Plasmodium species antigen IVD, kit, immunochromatographic test (ICT), rapid

DE-1
EN-1

Vk_20190703_41

02.07.2019 

(Updated 08.07.2019)

Medtronic MiniMed

Minimed Paradigm Insulin Pump
Model: MMT-512, MMT-712, MMT-515, MMT-715, MMT-522, MMT-722, MMT-554, MMT-754
S/N: All
SW-Version: See FSN

Minimed 508 Insulin Pump
Model: MMT-508
SW-Version: All

MD: Ambulatory insulin infusion pump, electronic

MD: Ambulatory insulin infusion pump, electronic

DE-1
FR-1
IT-1
EN-1

Vk_20190628_16

05.07.2019

Oertli Instrumente AG

Phaco Tips Easytip 2.2mm 30°
Model: VV800735A
Lot: 19.01000.01, 19.01333.01,19.01772.01,19.02238.01,19.02878.01, 19.03816.01, 19.05388.01, 19.05389.01

MD: Phacoemulsification system handpiece tip, reusable

DE-1
EN-1

Vk_20190705_02

04.07.2019 

(Updated 05.07.2019)

GBUK Enteral Ltd also trading as Enteral UK

nutricare Infant Feeding Tube
Model: NCI06.050ISOSAF-ROW
Lot: 18001594

MD: Gastrostomy tube

DE-1
FR-1
IT-1
EN-1

Vk_20190701_19

04.04.2019 

(Updated 05.07.2019)

Ethicon Endo-Surgery LLC

Ethicon Intraluminal Staplers (ILS)
Model: CDH21A, CDH25A, CDH29A, CDH33A, ECS21A, ECS25A, ECS29A, ECS33A
Lot: See FSN

MD: Intraluminal circular stapler, single-use

DE-1
DE-2
FR-1
FR-2
IT-1
IT-2
EN-1
EN-2

Vk_20190328_16

16.05.2019 

(Updated 04.07.2019)

WIROS Wilfried Rosbach GmbH

care&serve Premium Holz-Mundspatel
Model: REF 95800300 + 100321
Lot: 1217 + 1495

MD: Lingual Palatal Bars

DE-1
FR-1
IT-1

Vk_20190426_08

24.04.2019 

(Updated 04.07.2019)

Medtronic Inc.

Sherpa Active 6F Guide Catheter
Model: see FSN
Lot: All

MD: Vascular guide-catheter, single-use

DE-1
DE-2
FR-1
FR-2
EN-1
EN-2

Vk_20190416_11

02.07.2019

Edwards Lifesciences LLC

Edwards CENTERA Transcatheter Heart Valve System
Model: 9551S23, 9551S26, 9551S29

MD: Aortic transcatheter heart valve bioprosthesis, stent-like framework

DE-1
FR-1
IT-1
EN-1

Vk_20190702_14

02.07.2019

Heidelberg Engineering GmbH

SPECTRALIS
Model: All
SW-Version: All software versions with HEYEX2 database system

MD: Spectral-domain optical coherence tomography system

DE-1
FR-1

Vk_20190627_15

02.07.2019

Philips Medical Systems (Cleveland) Inc

Vereos PET/CT
Model: 882446
S/N: 900006, 900027

MD: PET/CT system

FR-1
EN-1

Vk_20190626_16

02.07.2019

Arrow International Inc.

Arterial Catheterization Set
Model: As per FSN
Lot: As per FSN

MD: Arterial blood pressure catheter

DE-1
FR-1
IT-1
EN-1

Vk_20190626_03

02.07.2019

Medical Intelligence Medizintechnik GmbH

HexaPOD evo RT System
Model: P10603-109, P10603-110, P10603-111
SW-Version: iGuide 2.2.0 – 2.2.2

MD: Tables, Radiotherapy

DE-1
FR-1
IT-1
EN-1

Vk_20190625_01

27.06.2019 

(Updated 02.07.2019)

Intuitive Surgical, Inc

da Vinci Xi EndoWrist SureForm 60 Reload
Model: 48360T-08, 48360G-08
Lot: See FSN

MD: Surgical staple loading unit, non-cutting

DE-1
EN-1

Vk_20190614_12

21.06.2019 

(Updated 02.07.2019)

Dexcom, lnc.

G4 Platinum System
Model: All receivers – applies to product generation

Dexcom G5 Mobile
Model: All receivers – applies to product generation

MD: Percutaneous glucose monitoring system

MD: Percutaneous glucose monitoring system

DE-1
FR-1
IT-1
EN-1

Vk_20190522_15

01.07.2019

GE Healthcare Finland Oy

ECG trunk cables

ECG Leadwire

MD: Electrical-only medical device connection cable, reusable

MD: Electrocardiographic lead set, reusable

DE-1
FR-1
IT-1
EN-1

Vk_20190627_10

25.06.2019 

(Updated 01.07.2019)

KeyMed Medical & Industrial Equipment

Nurses Control Panel Arm – Long
Model: MAJ-1664, K10021798
Lot: All lot numbers prior to 606852

MD: Medical device integration rack

DE-1
FR-1
IT-1
EN-1

Vk_20190621_22

01.07.2019

Bracco Injeneering S.A.

Day Set III HP
Model: 640060
Lot: 2018091403, 2018092003, 2018092004, 2019031101, 2019031601, 2019041904

MD: Contrast medium injection system syringe

DE-1
FR-1
IT-1
EN-1

Vk_20190619_17

 

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