Головна / Моніторинг Великобританія / Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.10.2019 – 31.12.2019

Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.10.2019 – 31.12.2019

Опубліковано 02.01.2020 о 11:06

Великобританія

https://www.gov.uk/drug–device–alerts?keywords=&alert_type[]=devices&issued_date[from]=&issued_date[to]=

 

  1. Arrow EZ-IO intraosseous vascular access needle sets – risk of needle stick injury

Manufactured by Teleflex Medical (Arrow) – do not use needles if the safety cap is not in place as the risk of needle stick injury is increased and sterility of the needle may be compromised if packaging is punctured.

  • Alert type: Medical device alert

 Medical specialism: Anaesthetics

 Issued: 19 December 2019

  1. ApexPro telemetry server – risk of loss of alarms for ECG and pulse oximetry monitoring (MDA/2019/045)

Manufactured by GE – central monitoring station or bedside monitor may not provide visual or audible alarms for ECG arrythmias, lead failures or SpO2 monitoring when used with affected telemetry system.

  • Alert type: Medical device alert

 Medical specialism: Anaesthetics and 15 others

 Issued: 18 December 2019

  1. BritePro Solo and BriteBlade Pro single-use fibre optic laryngoscope blades and handles – risk of choking (MDA/2019/044)

Manufactured by Flexicare Medical – loose bearings and retaining ring may enter patient’s airway causing choking hazard if the laryngoscope blade is disengaged from the handle above the patient.

  • Alert type: Medical device alert

 Medical specialism: Anaesthetics and 3 others

  • Issued: 12 December 2019
  1. Recall of Medicina IV Luer Slip syringe (IVS03) batch number 19040303 (MDA/2019/043)

Manufactured by Medicina – syringes incorrectly packaged with a needle could mean they are not sterile and could cause a needlestick injury.

  • Alert type: Medical device alert

 Medical specialism: Anaesthetics and 20 others

 Issued: 11 December 2019

  1. Natus gold cup electrodes and snap electrode leads – risk of electric shock

Manufactured by Natus – GN Otometrics A/S: an exposed conductor may cause an electric shock to the user or patient.

  • Alert type: Medical device alert

 

  • Issued: 5 December 2019
  1. Spectra Optia apheresis: anticoagulant bags used with ‘Correct Connect’ connectors – risk of unbroken ‘frangible’ connector during use (MDA/2019/041)

Manufactured by Terumo BCT – inadequately broken anticoagulant ‘frangible’ may lead to clotting and inadequate therapy during apheresis procedures.

  • Alert type: Medical device alert

 Medical specialism: Anaesthetics and 3 others

 Issued: 4 December 2019

  1. Alaris™ Gateway Workstation and Alaris™ Gateway Workstation web browser user interface (MDA/2019/040)

Manufactured by Becton Dickinson – if a software security vulnerability is exploited, an attacker with malicious intention could remotely install unauthorised firmware.

  • Alert type: Medical device alert

 Medical specialism: Anaesthetics and 14 others

 Issued: 27 November 2019

  1. Professional use defibrillator/monitor: Efficia DFM100 (Model number 866199) – risk of failure to switch on or unexpected restart (MDA/2019/039)

Manufactured by Philips – due to a software or hardware issue the device may fail to start or deliver defibrillation therapy.

  • Alert type: Medical device alert

 Medical specialism: Anaesthetics and 17 others

 Issued: 31 October 2019

  1. Syringe driver pumps: T34™ 3rd edition models only – stop using the pump until updated instructions for use and BodyCommTM V3.0 software are released (MDA/2019/038)

Manufactured by CME (a BD company) – the intended operation of these pumps cannot be verified due to errors in the instructions for use (IFUs) and the incompatibility with older versions of BodyComm software (88-102).

  • Alert type: Medical device alert

 Medical specialism: Care home staff and 3 others

 Issued: 29 October 2019

  1. Prismaflex haemofiltration systems installed with software versions 8.10, 7.20 and lower – risk of unexpected machine shutdown during treatment (MDA/2019/037)

Manufactured by Baxter – Communication error alarms may result in unintentional delay and interruption of treatment due to system shutdown.

  • Alert type: Medical device alert

 edical specialism: Anaesthetics and 4 others

 Issued: 10 October 2019

  1. Specific Hudson RCI Sheridan endotracheal tubes and connectors – 15 mm connector may detach from the tube before or during use (MDA/2019/036)

Manufactured by Teleflex Medical – disconnection can result in inadequate oxygenation and ventilation requiring medical intervention to avoid hypoxia, severe neurological injury or death.

  • Alert type: Medical device alert

 Medical specialism: Anaesthetics and 2 others

 Issued: 10 October 2019

  1. Rocket and NuSurgix fetal blood sampling (FBS) amnioscopes and FBS kits – stop using ethyl chloride spray during the fetal blood sampling procedure with these devices (MDA/2019/035)

Manufactured by Rocket Medical and NuSurgix – potential incompatibility between ethyl chloride spray and the device.

  • Alert type: Medical device alert

 Medical specialism: Obstetrics and gynaecology

 Issued: 9 October 2019

  1. Intraoperative probe cover with long Surgi-tip – risk of infection due to manufacturing failure (specific lot numbers affected) (MDA/2019/034)

Manufactured by Ecolab/Microtek Medical Malta Ltd – bacterial contamination may cause an infection in patients.

  • Alert type: Medical device alert

 Medical specialism: Anaesthetics and 12 others

 Issued: 9 October 2019

  1. Anaesthetic face masks – Specific Intersurgical Economy 22F taper connection may be oversized and leak or disconnect from the breathing circuit (MDA/2019/033)

Manufactured by Intersurgical – leaks or disconnection can result in insufficient oxygenation requiring medical intervention to avoid severe injury.

  • Alert type: Medical device alert

 Medical specialism: Anaesthetics and 2 others

 Issued: 8 October 2019

  1. Breathing circuit swivel elbow – recall due to risk of cracks forming before or during use (MDA/2019/032)

Manufactured by Intersurgical, used in devices made by other companies: cracks in swivel elbow connectors may lead to prescribed ventilation not being delivered.

  • Alert type: Medical device alert

 Medical specialism: Anaesthetics and 2 others

 Issued: 3 October 2019

 

 

 

 

Франція

https://ansm.sante.fr/S–informer/Informations–de–securite–Autres–mesures–de–securite

 

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30/12/2019 –Alerte– Appareil de radiologie fixe – RX- CombiDiagnost R90 – Philips Medical Systems DMC GmbH – Information de sécurité

30/12/2019 –Alerte– Système de Sabre Fémoral – Askorn Medical– Rappel

30/12/2019 –Alerte– Esthétique – Matrice de régénération dermique monocouche – Integra Lifesciences- Information de sécurité

24/12/2019 –Instrumentation endoscopique utilisée en chirurgie robotique – Plateau pour endoscope Da Vinci Xi et plateau pour caméra portative – Intuitive Surgical Inc – Information de sécurité

24/12/2019 –Ventilateur d’anesthésie – Carestation 600 – GE Healthcare – Information de sécurité

23/12/2019 –Alerte– Défibrillateur externe – Defigard Touch 7 – Schiller Medical – Information de sécurité

20/12/2019 –Alerte– Appareil de radiologie interventionnelle- RX- Azurion & Allura system, R1.2.x and R2.0.x – Philips medical Systems Nederland B.V – Information de sécurité

20/12/2019 –Alerte– Spirales Azur CX détachables 35 et spirales d’embolisation endovasculaire Azur détachable 18 Terumo Microvention Inc. – Information de sécurité

19/12/2019 –Alerte– Déambulateur Rollator Ligero – Dieter Marquardt Medizintechnik GmbH – Information de sécurité

19/12/2019 –Alerte– Raccord pour perfusion – Raccords de préparation / administration de chimiothérapie – Cair Lgl – Information de sécurité

17/12/2019 –Alerte– Ventilateur pour usage à domicile – Stellar 100 et Stellar 150 – ResMed – Information de sécurité

16/12/2019 –Alerte– Défibrillateur externe – Tempus LS, Schiller AG – Information de sécurité

16/12/2019 –Alerte– Ciment chirurgical (orthopédie) – Optipac – Zimmer Biomet – Information de sécurité

16/12/2019 –Alerte– Canulepour CEC- Quickdraw – Peripheral venous access cannula – Edwards Lifesciences LLC – Information de sécurité

16/12/2019 –Alerte– Appareil de radiothérapie – Stereotacticradiotherapy – ViewRay Inc. – Information de sécurité

13/12/2019 –Câble modulaire pour assistance ventriculaire HeartMate 3 Abbott / Thoratec – Information de sécurité

13/12/2019 –Unité d’alimentation mobile pour assistance ventriculaire gauche HeartMate 3 Abbott / Thoratec Corporation – Information de sécurité

12/12/2019 –Stents Cordis S.M.A.R.T et Precise – Cordis Corporation – Information de sécurité

12/12/2019 –Désinfectant pour STE/Endoscopie – Phago’scope Apa – Christeyns France – Information de sécurité

10/12/2019 –Alerte– Défibrillateur externe – HeartStart XL+ – Philips Medical System – Information de sécurité

10/12/2019 –LAP : Logiciel aide à la prescription – Osiris – Corwin- Information de sécurité

10/12/2019 –Ventilateur pour usage à domicile – Trilogy Evo – Philips – Information de sécurité

09/12/2019 –Alerte– Poche graduée de recueil de fluides biologiques utilisée avec un champ sous-fessier d’accouchement – Medline – Information de sécurité

09/12/2019 –Alerte– Défibrillateur externe – Efficia DFM 100 – Philips – Information de sécurité

05/12/2019 –Alerte– Pompe implantable – Kit de remplissage et kit de site d’accès pour cathéter IsoMed – Medtronic France – Information de sécurité

05/12/2019 –Alerte– Défibrillateur externe – HeartStart XL+ – Philips Medical Systems – Information de sécurité

04/12/2019 –Alerte– Prothèse d’épaule (orthopédie) – Tiges humérales Aequalis Ascend Flex – Tornier – Information de sécurité

04/12/2019 –Alerte– Laryngoscope – C-Mac® Videolaryngoscope – Karl Storz Se & Co – Information de sécurité

04/12/2019 –Alerte– Appareil de radiologie interventionnelle- Cios Alpha – Siemens- Information de sécurité

02/12/2019 –Bistouri électrique – Générateurs électrochirurgicaux Valleylab FT10, FX8, LS10 – Medtronic/Covidien – Information de sécurité

02/12/2019 –Alerte– Systèmes de caméras opératoires TIVITA avec chariots motorisés – Diaspective Vision – Information de sécurité

02/12/2019 –Dispositif de réparation des valves cardiaques – Système de reconstruction de la valve mitrale ou tricuspide Cardioband – Edwards Lifesciences LLC – Information de sécurité

29/11/2019 –Alerte– Pompe à insuline externe – MiniMed série 600 : Pompe à insuline Medtronic MiniMed™ 640G – Medtronic- Information de sécurité

29/11/2019 –Alerte– Chirurgie du rachis – Cages cervicale et lombaires EIT Cellular Titanium – TLIF et PLIF- EIT Emerging Implant Technologies (Depuy Synthes) – Information de sécurité

29/11/2019 –Alerte– Orthopédie – Composant en polyéthylène de la prothèse de cheville STAR – STRYKER – Information de sécurité

28/11/2019 –Alerte– Radiologie interventionnelle – O-arm – Medtronic – Information de sécurité

28/11/2019 –Alerte– Radiothérapie (logiciel) – RayStation/RayPlan static arcs – RaySearch Laboratories AB – Information de sécurité

27/11/2019 –Matériel ancillaire (orthopédie) – Maillet Profix 750g – Smith & Nephew – Information de sécurité

27/11/2019 –Alerte– Sous population de défibrillateurs cardiaques implantables Visia AF, Visia AF MRI, Evera et Evera MRI et de défibrillateurs cardiaques implantables avec thérapie de resynchronisation Claria MRI, Amplia MRI et VIVA – Medtronic France – Information de sécurité

26/11/2019 –Alerte– Lentille intra-oculaire préchargée – Logiciel aide au calcul des lentilles Artis T PLE – Cristalens Industrie – Information de sécurité

26/11/2019 –Nutrition entérale (sonde) – Sondes de nutrition entérale naso-duodénales adultes – Cair LGL – Information de sécurité

26/11/2019 –Alerte– Curiethérapie – Flexitron HDR – Flexitron Cobalt-60 – Elekta – Information de sécurité

26/11/2019 –Alerte– Cardiologie – Programmateurs CareLink et CareLink Encore™ – Medtronic Inc – Information de sécurité

25/11/2019 –Moniteur de surveillance (accessoire) – Modules respiratoires Carescape – GE Healthcare – Information de sécurité

25/11/2019 –Duodénoscope / Endoscopie – Duodénoscope et Vidéoduodénoscope TJF-160R, TJF-140R, JF-140R, TJF-240, JF-240, JF-1T40 et JF-TE3 – Olympus – Information de sécurité

25/11/2019 –Bistouri à ultrason (électrode/manche) – Cusa Clarity Console – Integra LifeSciences Ltd – Information de sécurité

25/11/2019 –Alerte– Pacs – Telemis-Medical – Telemis – Information de sécurité

25/11/2019 –Alerte– Système de traitement d’images numériques – Tomtec-Arena – Tomtec Imaging Systems – Information de sécurité

22/11/2019 –Alerte– Stérilisateur/stérilisation – Steam Sterilizer, Getinge Sterilization AB – Information de sécurité

22/11/2019 –Moteur pour système de CEC ou d’Ecmo – CentriMag™ Acute Circulatory Support System Motor – Abbott Medical – Information de sécurité

21/11/2019 –Alerte– Set de perfusion – Arrow® EZ-IO – Teleflex Medical Europe Ltd – Information de sécurité

20/11/2019 –Thermomètre tympanique – Genius 2 et 3 – Covidien – Information de sécurité

19/11/2019 –Anesthésie loco-régionale – Cathéter multiperforé Profilis PaincAth – Districlass Medical – Information de sécurité

19/11/2019 –LAP : Logiciel aide à la prescription – Evolucare Intensive, Reassist et Osiris – Corwin ETCCS – Information de sécurité

18/11/2019 –Moniteur d’hémodialyse Dialog+ – B. Braun Avitum AG – Information de sécurité

15/11/2019 –Appareil de radiologie fixe – Systèmes Apollo/DRF/EZ/EZ DRF – Villa Sistemi Medicali Spa – Information de sécurité

14/11/2019 –Alerte– Circuit ou Pack pour Ecmo – Deltastream DP3 Pumphead, Xenios AG – Fresenius Medical Care France – Information de sécurité

14/11/2019 –Alerte– Ventilateur de réanimation – Bellavista série 1000 et 950 – IMTmedical – Information de sécurité

14/11/2019 –Alerte– Dispositif intra-utérin – Sethygyn (kit complet de pose et stérilet) – Stérilet seul Ancora 375 Cu Normal, Gold T® et Novaplus : T 380 Ag Maxi, T 380 Ag Mini, T 380 Ag Normal, T 380 Cu Mini, T 380 Cu Normal – Eurogine – Euromedial – Information de sécurité

14/11/2019 –Scanner-RX- Somatom go – Information de sécurité

14/11/2019 –Alerte– Dispositif de télémétrie – ApexPro Telemetry System – GE Medical Systems – Information de sécurité

13/11/2019 –Alerte– Matériel ancillaire (hanche) – Ancillaire pour tige Optimal® – Amplitude – Information de sécurité

07/11/2019 –Alerte– Orthopédie – Tarières du système TLS – FH Orthopedics- Information de sécurité

07/11/2019 –Alerte– Récupérateur de sang – Kit de bol Cell saver 5/5+ – Haemonetics Corporation – Information de sécurité

07/11/2019 –Alerte– Moniteur d’hémodialyse Prismaflex System, Prismaflex 4.11, Prismaflex 5.00 Row, Prismaflex 6.10 Row, Prismaflex 7.XX Row – Gambro Lundia AB – Information de sécurité

04/11/2019 –Neurostimulateur (accessoire) – Application A610 version 1.0.3470 du programmateur médecin – Medtronic Inc – Information de sécurité

31/10/2019 –Alerte– Table de verticalisation – Akron Tilt Table – Arjo Huntleigh AB – Information de sécurité

30/10/2019 –Réchauffeur/Humidificateur – Chambre d’humidification à remplissage automatique – DEAS SRL – Information de sécurité

29/10/2019 –Dispositif intra-vaginal – Sets de prélèvement au scalp foetal – Nursurgix – Information de sécurité

29/10/2019 –Rotatif dentaire – Ti-Max Z, S-Max M, Pana-Max et Ti-Max X – NSK – Information de sécurité

29/10/2019 –Fauteuil de repos – Chaise de travail Euroflex avec châssis Forma – Eurovema AB – Information de sécurité

28/10/2019 –Ventilateur de réanimation V60, V680 et pièces détachées – Philips – Information de sécurité

25/10/2019 –Prothèse totale de hanche – Tige fémorale (orthopédie) – Tige fémorale monobloc cimentée H-MAX C – Lima Corporate – Information de sécurité

24/10/2019 –Alerte– Scanner-RX – Somatom + syngo CT VB10 ou CT VB20 – Siemens Healthcare GmbH – Information de sécurité

24/10/2019 –Alerte– Programmateurs & Applications logicielles de télésurveillance de stimulateurs cardiaques implantables, de stimulateurs cardiaques implantables de resynchronisation (CRT-P), de défibrillateurs cardiaques implantables (DAI), défibrillateurs cardiaques implantables de resynchronisation (CRT-D) et de systèmes de stimulation transcathéters (TPS) Micra™ – Medtronic – Information de sécurité

22/10/2019 –Dispositif de bloc opératoire (divers) – Récipients MediTainer, MediBowl, MEdiDuo – Omni-Pac Ekco GmbH – Information de sécurité

17/10/2019 –Alerte– Centrale de surveillance – Xhibit Central Station modèle 96102 – Spacelabs Healthcare Inc – Information de sécurité

15/10/2019 –Régulateur de vide – MediEject II – GCE SAS – Information de sécurité

14/10/2019 –Implantologie dentaire – Pilier standard droit 05.0mm H3mm KP503 et Pilier conique angulé 17° H3mm KEA173 – Biotech Dental – Information de sécurité

14/10/2019 –Alerte– Ventilateur pour usage à domicile – Monnal T50 – Air Liquide Medical Systems – Information de sécurité

10/10/2019 –Baie d’électrophysiologie -CardioLab, ComboLab – GE Healthcare Clinical Systems – Information de sécurité

10/10/2019 –Alerte– Orthopédie – Moteur SmartLife Large Aseptic Housings – Stryker- Information de sécurité

09/10/2019 –Alerte– Stop-vide pédiatrique Med-Stop – Medline – Information de sécurité.

08/10/2019 –Alerte– Système régulation température corporelle – Norm-O-Temp, Gentherm Medical – Information de sécurité

08/10/2019 –Alerte– Moniteur d’hémodialyse – TherMax Blood Warmer Unit, Row – Baxter Healthcare – Information de sécurité

08/10/2019 –Echographe Ultrason – S7-3t & S8-3t Transesophageal (TEE) Transducers – Philips- Information de sécurité

07/10/2019 –Implantologie dentaire – In-Kone• Universal – Global D – Information de sécurité

07/10/2019 –Alerte– Logiciel de radiothérapie – Iplan – Brainlab – Information de sécurité

04/10/2019 –Alerte– Stimulateurs cardiaques implantables double chambre – Adapta™, Versa™, Sensia™, Relia™, Attesta™, Sphera™, et Vitatron™ Séries A, E, G, Q – Medtronic – Information de sécurité

04/10/2019 –Alerte– Défibrillateur externe – Efficia DFM 100, Philips- Information de sécurité

03/10/2019 –Alerte– Scanner – RX- Access – Philips Healthcare Co. Ltd – Information de sécurité

01/10/2019 –Alerte– Incubateur Embryology Heated Plate Coopersurical dans le RI Witness TM – Coopersurgical Inc – Information de sécurité

 

Німеччина

 

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Urgent Field Safety Notice for Sterile Tube Packaging by Synthes GmbH

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Urgent Field Safety Notice for CUSA Clarity Console by Integra LifeSciences Corp Tullamore

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Urgent Field Safety Notice for Volista by MAQUET SAS

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Urgent Field Safety Notice for Stellar by ResMed Ltd.

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PDF45KB

  • 12.13

Urgent Field Safety Notice for MiniMed 640G pump, MiniMed 670G pump by Medtronic Minimed

Injections / Infusions / Transfusions / Dialysis – infusion technology

PDF385KB

  • 12.13

Urgent Field Safety Notice for Cannulated TLS DRILL BIT Ø 2.5 (254 537 – 253 165 – 251 830 – 250 102 – by FH Orthopedics INC

Medical instruments for use in humans – bone surgery

PDF486KB

  • 12.13

Urgent Field Safety Notice for Weichteilretraktor, röntgentransparent by aap Implantate AG

Medical instruments for use in humans – general instruments

PDF197KB

  • 12.12

Urgent Field Safety Notice for Healon GV PRO by AMO Uppsala AB

ophthalmological technology – liquid media for ophthalmological purposes

PDF2MB

  • 12.12

Urgent Field Safety Notice for HNO-Set by Angiokard Medizintechnik GmbH

Medical instruments for use in humans – general instruments

PDF16KB

  • 12.10

Urgent Field Safety Notice for Discovery MR750w 3.0T, MR750 3.0T und MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, Artist und PET/MR by GE Medical Systems, LLC

Electromedical fields – equipment for MR tomography

PDF214KB

  • 12.10

Urgent Field Safety Notice for WegaMed by TESCOM EUROPE GMBH & CO. KG

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF300KB

  • 12.10

Urgent Field Safety Notice for MRIdian Linac System by ViewRay Inc.

Radiotherapy / Radiation protection – radiation facilites with accelerators for teletherapy

PDF324KB

  • 12.09

Urgent Field Safety Notice for Trilogy Evo, Garbin Evo, LifeVent Evo2 by Philips Respironics, Inc.

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF2MB

  • 12.06

Urgent Field Safety Notice for intrauterine pessaries Ancora, Novaplus and Gold-T by Eurogine S.L.

Contraception – intrauterine device

PDF167KB

  • 12.06

Urgent Field Safety Notice for QuickDraw Venous Cannula by Edwards Lifesciences LLC

Injections / Infusions / Transfusions / Dialysis – catheters

PDF182KB

  • 12.06

Urgent Field Safety Notice for GTS Raspel by Biomet France SARL

Medical instruments for use in humans – bone surgery

PDF407KB

  • 12.06

Urgent Field Safety Notice for Tempus LS by Schiller AG

Medical electronics / Electromedical devices – electrotherapy

PDF2MB

  • 12.06

Urgent Field Safety Notice for HeartMate 3 by Thoratec Corporation

Active implantable medical devices – artificial hearts

PDF113KB

  • 12.06

Urgent Field Safety Notice for Dexcom G6 CGM System by Dexcom, Inc.

Medical electronics / Electromedical devices – electric blood glucose meters

PDF603KB

  • 12.06

Urgent Field Safety Notice for C-RAD Gating Box HZ-009. c4D Software by C-RAD Positioning AB

Radiological technology – navigation systems

PDF10MB

  • 12.06

Urgent Field Safety Notice for HeartMate 3 by Thoratec Corporation

Active implantable medical devices – artificial hearts

PDF103KB

  • 12.05

Urgent Field Safety Notice for lic2 (low impadance cream) by SOMNOmedics GmbH

Dressings / Pads – ointments and gels

PDF1MB

  • 12.04

Urgent Field Safety Notice for Skalpellklinge, Fig 15 steril by Gebrüder Martin GmbH & Co. KG

Medical instruments for use in humans – general instruments

PDF4MB

  • 12.04

Urgent Field Safety Notice for BritePro Solo Single Use Fibre Optic Laryngoscope by Flexicare Medical Limited

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

PDF2MB

  • 12.03

Urgent Field Safety Notice for Durapore Advanced Surgical Tape by 3M Deutschland GmbH

Dressings / Pads – bandages

PDF43KB

  • 12.03

Urgent Field Safety Notice for Mitek HEALIX ADVANCE, HEALIX ADVANCE Knotless, MILAGRO ADVANCE, and INTRAFIX Advance by DePuySynthes Mitek Sports Medicine

Non-active implants – bone surgery

PDF271KB

  • 11.22

Urgent Field Safety Notice for CARESCAPE-Beatmungsmodule E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE by GE Healthcare Finland Oy

Medical electronics / Electromedical devices – electrodiagnostics

PDF364KB

  • 11.22

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

Radiotherapy / Radiation protection – radiotherapy treatment planning systems

PDF74KB

  • 11.22

Urgent Field Safety Notice for PneumoDart by TyTek Medical Inc.

Injections / Infusions / Transfusions / Dialysis – syringes and cannulas

PDF101KB

  • 11.22

Urgent Field Safety Notice for GORE DrySeal Flex Introducer Sheath by W.L. Gore & Associates, Inc.

Injections / Infusions / Transfusions / Dialysis – catheters

PDF633KB

  • 11.22

Urgent Field Safety Notice for Aespire 7100, Aestiva 7900/MRI/7100/100 by Datex-Ohmeda, Inc.

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF205KB

  • 11.21

Urgent Field Safety Notice for MediEject II by GCE s.r.o.

Injections / Infusions / Transfusions / Dialysis – drainages and suction systems

PDF3MB

  • 11.21

Urgent Field Safety Notice for CHA Anesthesia and CHA Critical Care by GE Healthcare

Medical electronics / Electromedical devices – electrodiagnostics

PDF272KB

  • 11.21

Urgent Field Safety Notice for Giraffe Omnibed and Giraffe Incubator; Giraffe Warmer, Panda i.e. Warmer by Datex-Ohmeda, Inc

Physical therapy – climatotherapy

PDF407KB

  • 11.21

Urgent Field Safety Notice for Luftkalorisator / Air Calorisator by Homoth Medizinelektronik GmbH & Co.KG

Medical electronics / Electromedical devices – ENT equipment

PDF962KB

  • 11.21

Urgent Field Safety Notice for CHA Anesthesia and CHA Critical Care by GE Healthcare

Medical electronics / Electromedical devices – electrodiagnostics

PDF203KB

  • 11.20

Urgent Field Safety Notice for MEDUCORE Standard 2 by WEINMANN Emergency Medical Technology GmbH + Co. KG

Medical electronics / Electromedical devices – electrotherapy

PDF46KB

  • 11.20

Urgent Field Safety Notice for Syramed µSP6000 by Arcomed AG

Injections / Infusions / Transfusions / Dialysis – infusion technology

PDF112KB

  • 11.19

Urgent Field Safety Notice for Prometra Programmable Pump by Flowonix Medical

Active implantable medical devices – drug pumps

PDF5MB

  • 11.19

Urgent Field Safety Notice for PRECISE, S.M.A.R.T., S.M.A.R.T. Control by Cordis Corporation

Non-active implants – special implants

PDF218KB

  • 11.18

Urgent Field Safety Notice for Taylor Dura Schere, Cushing Dura Haken, Frazier Du by Ortho Select GmbH

Medical instruments for use in humans – neurosurgery

PDF101KB

  • 11.15

Urgent Field Safety Notice for Artis zee by Siemens Healthcare GmbH, X-Ray Products (XP)

Radiological technology – radiological equipment for vascular diagnostics

PDF730KB

  • 11.15

Urgent Field Safety Notice for AngioJet Ultra 5000A Console Foot Switch by Boston Scientific Corporation Marlborough

Surgical equipment/ Anaesthesia – surgical equipment

PDF820KB

  • 11.15

Urgent Field Safety Notice for Combihesive Natura, konvexe Basisplatte by ConvaTec

Orthopaedic / Rehabilitation technology – care of natural and artificial body orifices

PDF1MB

  • 11.14

Urgent Field Safety Notice for PASCAL Transcatheter Mitral Valve Repair System by Edwards Lifesciences LLC

Non-active implants – cardiac surgery

PDF190KB

  • 11.14

Urgent Field Safety Notice for LIGAMAX-5 5MM Endoscopic Multiple Clip Applier by Ethicon Endo-Surgery, LLC.

Medical instruments for use in humans – general instruments

PDF262KB

  • 11.14

Urgent Field Safety Notice for Orchestra Base Intensive and Orchestra Base Primea by Fresenius Vial Infusion Technologie

Injections / Infusions / Transfusions / Dialysis – infusion technology

PDF80KB

  • 11.13

Urgent Field Safety Notice for PROFIX 750 Gr. Mallet Cleaning&Sterilization Guide by Smith & Nephew, Inc.,

General equipment for medical treatment – cleaning / disinfection / sterilisation

PDF217KB

  • 11.13

Urgent Field Safety Notice for Beneview T5-Monitore by Shenzhen Mindray Bio-Medical Electronics Co. Ltd

Medical electronics / Electromedical devices – electrodiagnostics

PDF95KB

  • 11.13

Urgent Field Safety Notice for Apex Pro Telemetry System by GE Medical Systems Information Technologies

Medical electronics / Electromedical devices – electrodiagnostics

PDF259KB

  • 11.13

Urgent Field Safety Notice for UNISEPTA FOAM 2 WIPES by USF Healthcare SA

General equipment for medical treatment – cleaning / disinfection / sterilisation

PDF730KB

  • 11.13

Urgent Field Safety Notice for Bohrer 1 für CS 3902, CS 3903, CS 3904 by Ulrich GmbH & Co. KG

Medical instruments for use in humans – bone surgery

PDF183KB

  • 11.12

Urgent Field Safety Notice for Rheumatoid Factor Kit for use on SPAPLUS by The Binding Site Group Limited

In-vitro diagnostics – equipment / products for clinical chemistry

PDF3MB

  • 11.12

Urgent Field Safety Notice for EIT Implants (Cervical, PLIF, TLIF) by EIT Emerging Implant Technologies GmbH

Non-active implants – bone surgery

PDF589KB

  • 11.12

Urgent Field Safety Notice for iChemVELOCITY Urine Chemistry Analyzer,iQ200 Urine Microscopy Analyzer by Beckman Coulter Ireland Inc.

In-vitro diagnostics – equipment / products for clinical chemistry

PDF101KB

  • 11.12

Urgent Field Safety Notice for OPASTER’ANIOS by Laboratoires ANIOS (DMD)

General equipment for medical treatment – cleaning / disinfection / sterilisation

PDF281KB

  • 11.12

Urgent Field Safety Notice for BACCIDE KIT PRO, ECI MND PREMIUM, INTRUNET SURFA SAFE PREMIUM, SURFA’SAFE PREMIUM by Laboratoires ANIOS (DMD)

General equipment for medical treatment – cleaning / disinfection / sterilisation

PDF2MB

  • 11.12

Urgent Field Safety Notice for Humeral Anatomical Metaphysis by Medacta International SA

Non-active implants – bone surgery

PDF32KB

  • 11.12

Urgent Field Safety Notice for Micro Scan Walk Away-40,Micro Scan Walk Away-96,DxM 1040 MicroScan WalkAway, DxM 1096 MicroScan WalkAway by Beckman Coulter, Inc.

In-vitro diagnostics – equipment / products for clinical chemistry

PDF4MB

  • 11.12

Urgent Field Safety Notice for VENTANA HE 600 System by Ventana Medical Systems Inc. (Mountain View)

In-vitro diagnostics – instruments, apparatuses and systems

PDF525KB

  • 11.12

Urgent Field Safety Notice for FTD BKV by Fast-Track Diagnostics S.a.r.l.

In-vitro diagnostics – microbiological products

PDF171KB

  • 11.12

Urgent Field Safety Notice for BacT/ALERT VIRTUO Microbial Detection System by bioMérieux Inc

In-vitro diagnostics – equipment / products for clinical chemistry

PDF59KB

  • 11.12

Urgent Field Safety Notice for Thromborel S by Siemens Healthcare Diagnostics Products GmbH

In-vitro diagnostics – haematological, histological and cytological products

PDF1MB

  • 11.12

Urgent Field Safety Notice for Alinity ci-series System Control Module (SCM) by Abbott GmbH & Co. KG

In-vitro diagnostics – equipment / products for clinical chemistry

PDF108KB

  • 11.12

Urgent Field Safety Notice for iChem Velocity Automated Urine Chemistry System by IRIS International

In-vitro diagnostics – equipment / products for clinical chemistry

PDF95KB

  • 11.12

Urgent Field Safety Notice for 03R65-01: Alinity i Processing Module; 03R67-01: Alinity c Processing Module; 04S68-02: Level Sensor, Bulk Solution; 03R66-03: Accessory kit, Alinity i; 03R69-03/03R69-04: Accessory kit #2, Alinity c by Abbott GmbH & Co.KG

In-vitro diagnostics – equipment / products for clinical chemistry

PDF115KB

  • 11.12

Urgent Field Safety Notice for DC-Screening II by DiaMed GmbH

In-vitro diagnostics – immunological products

PDF2MB

  • 11.12

Urgent Field Safety Notice for BD CHROMagar Orientation Medium by Becton Dickinson GmbH, Regulatory & Public Affairs

In-vitro diagnostics – microbiological products

PDF217KB

  • 11.11

Urgent Field Safety Notice for Genius 2 /Genius 3 by Cardinal Health Ireland Manufacturing Ltd

Medical electronics / Electromedical devices – electrodiagnostics

PDF198KB

  • 11.11

Urgent Field Safety Notice for V60 Ventilator by Respironics California, Inc.

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF317KB

  • 11.11

Urgent Field Safety Notice for V60 Ventilator by Respironics California, Inc.

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF381KB

  • 11.11

Urgent Field Safety Notice for V60 Ventilator by Respironics California, Inc.

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF212KB

  • 11.11

Urgent Field Safety Notice for V680 Ventilator by Respironics California, Inc.

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF177KB

  • 11.08

Urgent Field Safety Notice for NxStage System One by NxStage Medical

Injections / Infusions / Transfusions / Dialysis – dialysis technology

PDF3MB

  • 11.07

Urgent Field Safety Notice for TIVITA Tissue by Diaspective Vision GmbH

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

PDF275KB

  • 11.07

Urgent Field Safety Notice for MicroAire SmartRelease Handpiece by MicroAire Surgical Instruments, Inc.

Medical instruments for use in humans – bone surgery

PDF9MB

  • 11.07

Urgent Field Safety Notice for Instrument set for OPTIMAL stem by Amplitude S.A.S.

Medical instruments for use in humans – bone surgery

PDF684KB

  • 11.07

Urgent Field Safety Notice for RayStation by RaySearch Laboratories AB

Radiotherapy / Radiation protection – radiotherapy treatment planning systems

PDF96KB

  • 11.06

Urgent Field Safety Notice for Torcon NB Advantage Catheter by Cook Incorporated

Injections / Infusions / Transfusions / Dialysis – catheters

PDF149KB

  • 11.06

Urgent Field Safety Notice for S.ÜLSCHLAUCHSET MIT ANSTECHDORN by Richard Wolf GmbH

Surgical equipment/ Anaesthesia – surgical equipment

PDF399KB

  • 11.06

Urgent Field Safety Notice for synedra AIM by Synedra Information Technologies GmbH

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

PDF2MB

  • 11.06

Urgent Field Safety Notice for Various Products by Waldemar Link GmbH & Co. KG

Non-active implants – bone surgery

PDF4MB

  • 11.06

Urgent Field Safety Notice for Artiset HD DNL HC; Artset pre-post by Gambro Dasco S.p.A.

Injections / Infusions / Transfusions / Dialysis – dialysis technology

PDF32KB

  • 11.06

Urgent Field Safety Notice for Standard C Cem standard / lateralisierend by Waldemar Link GmbH & Co. KG

Non-active implants – bone surgery

PDF3MB

  • 11.05

Urgent Field Safety Notice for BAGUERA C / BAGUERA L by SPINEART S. (Plan-Les-Ouates)

Non-active implants – bone surgery

PDF791KB

  • 11.05

Urgent Field Safety Notice for Passive Biopsy Needle Kit by Medtronic Navigation Inc.

Medical instruments for use in humans – general instruments

PDF92KB

  • 11.05

Urgent Field Safety Notice for PROTEK Duo ECLS Cannula 29Fr & PROTEK Duo ECLS Kit (Subset) by CardiacAssist

Surgical equipment/ Anaesthesia – surgical equipment

PDF1MB

  • 11.04

Urgent Field Safety Notice for Syramed µSP6000 and Volumed µVP7000 by Arcomed AG

Injections / Infusions / Transfusions / Dialysis – infusion technology

PDF112KB

  • 11.04

Urgent Field Safety Notice for Levó Arm by Mizuho Orthopedic Systems, Inc.

Radiotherapy / Radiation protection – others

PDF2MB

  • 11.04

Urgent Field Safety Notice for TOMTEC-ARENA by TomTec Imaging Systems

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

PDF92KB

  • 10.31

Urgent Field Safety Notice for TherMax Blood Warmer Unit, ROW by Baxter Healthcare S. (Opfikon)

Injections / Infusions / Transfusions / Dialysis – dialysis technology

PDF82KB

  • 10.31

Urgent Field Safety Notice for XEN 45 GTS by Allergan Inc.

Non-active implants – special implants

PDF75KB

  • 10.30

Urgent Field Safety Notice for Bard Max-Core Disposable Core Biopsy Instrument by Bard Peripheral Vascular Inc. (BPV)

Medical instruments for use in humans – general instruments

PDF237KB

  • 10.30

Urgent Field Safety Notice for Fetal Blood Sampling kit _ R57024-00-SW by Rocket Medical plc

Injections / Infusions / Transfusions / Dialysis – syringes and cannulas

PDF516KB

  • 10.30

Urgent Field Safety Notice for Rollator B by Bischoff & Bischoff Medizin- und Rehabilitationstechnik GmbH

Orthopaedic / Rehabilitation technology – daily living aids

PDF470KB

  • 10.30

Urgent Field Safety Notice for Emerge Monorail, NC Emerge Monorail PTCA-Dilatationskatheter by Boston Scientific Corporation Marlborough

Injections / Infusions / Transfusions / Dialysis – catheters

PDF371KB

  • 10.29

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

In-vitro diagnostics – equipment / products for clinical chemistry

PDF46KB

  • 10.29

Urgent Field Safety Notice for Optilite Rheumatoid Factor kit by The Binding Site Group Limited

In-vitro diagnostics – immunological products

PDF5MB

  • 10.29

Urgent Field Safety Notice for BIOPHEN ARIXTRA CONTROL PLASMA by HYPHEN BioMed SAS

In-vitro diagnostics – equipment / products for clinical chemistry

PDF91KB

  • 10.29

Urgent Field Safety Notice for VIDAS 3 System by BioMérieux SA

In-vitro diagnostics – instruments, apparatuses and systems

PDF815KB

  • 10.29

Urgent Field Safety Notice for Atellica IM Active-B12 (Holotranscobalamin) (AB12) by Siemens Healthcare Diagnostics Inc. Tarrytown

In-vitro diagnostics – equipment / products for clinical chemistry

PDF45KB

  • 10.29

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

In-vitro diagnostics – equipment / products for clinical chemistry

PDF443KB

  • 10.29

Urgent Field Safety Notice for V680 Ventilator by Respironics California, Inc.

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF2MB

  • 10.29

Urgent Field Safety Notice for FTD Hepatitis E RNA by Fast-Track Diagnostics S.a.r.l.

In-vitro diagnostics – microbiological products

PDF131KB

  • 10.29

Urgent Field Safety Notice for Diacon P by DIALAB GmbH

In-vitro diagnostics – equipment / products for clinical chemistry

PDF2MB

  • 10.29

Urgent Field Safety Notice for MRX PT Owren’s by MediRox AB

In-vitro diagnostics – equipment / products for clinical chemistry

PDF166KB

  • 10.28

Urgent Field Safety Notice for EZ Glide Aortic Cannula by Edwards Lifesciences LLC

Injections / Infusions / Transfusions / Dialysis – catheters

PDF478KB

  • 10.24

Urgent Field Safety Notice for Advanix Pancreatic Stent by Boston Scientific Corporation Marlborough

Non-active implants – special implants

PDF156KB

  • 10.24

Urgent Field Safety Notice for HeartStart XL+ by Philips Healthcare

Medical electronics / Electromedical devices – electrotherapy

PDF1MB

  • 10.24

Urgent Field Safety Notice for Absorbent table covers by Microtek Medical, B.V.

Dressings / Pads – pads and diapers

PDF79KB

  • 10.24

Urgent Field Safety Notice for HeartStart XL+ by Philips Healthcare

Medical electronics / Electromedical devices – electrotherapy

PDF478KB

  • 10.22

Urgent Field Safety Notice for X-Change by Howmedica Osteonics Corporation

Medical instruments for use in humans – bone surgery

PDF89KB

  • 10.22

Urgent Field Safety Notice for Weck Hem-o-Lok Ligating Clips Auto Endo5 ML by Teleflex Medical (North Carolina)

Medical instruments for use in humans – general instruments

PDF202KB

  • 10.22

Urgent Field Safety Notice for Basispfosten für Epithesenplatten by Medicon eG

Non-active implants – bone surgery

PDF319KB

  • 10.22

Urgent Field Safety Notice for Monnal T50 by Air Liquide Medical Systems

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF126KB

  • 10.22

Urgent Field Safety Notice for SYNCHROMED II by Medtronic Inc

Active implantable medical devices – drug pumps

PDF182KB

  • 10.22

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

Dressings / Pads – others

PDF99KB

  • 10.21

Urgent Field Safety Notice for Angiodyn by PendraCare International

Injections / Infusions / Transfusions / Dialysis – catheters

PDF367KB

  • 10.18

Urgent Field Safety Notice for GSS67H by Getinge Sterilization AB

General equipment for medical treatment – cleaning / disinfection / sterilisation

PDF25KB

  • 10.16

Urgent Field Safety Notice for Monolithic cemented and cementless stems by Lima Corporate S.p.A.

Non-active implants – bone surgery

PDF319KB

  • 10.16

Urgent Field Safety Notice for MaxZero Needleless Connector by Impromediform GmbH

Injections / Infusions / Transfusions / Dialysis – infusion technology

PDF121KB

  • 10.16

Urgent Field Safety Notice for GuardiaT Access, Guardia Access Nano by Cook Incorporated / Cook Vascular

Injections / Infusions / Transfusions / Dialysis – catheters

PDF93KB

  • 10.16

Urgent Field Safety Notice for DTX Safedraw Kits and Meritrans DTXPlus Devices by Merit Medical Systems Inc.

Medical electronics / Electromedical devices – electronic blood pressure monitor

PDF226KB

  • 10.15

Urgent Field Safety Notice for HCYS – Homocysteine enzymatic assay by Roche Diagnostics GmbH

In-vitro diagnostics – equipment / products for clinical chemistry

PDF288KB

  • 10.15

Urgent Field Safety Notice for SPOT-it TK and SPOT-it T Newborn Screening kits by ImmunoIVD AB

In-vitro diagnostics – haematological, histological and cytological products

PDF2MB

  • 10.15

Urgent Field Safety Notice for Liquid Cardiac Control by Randox Laboratories Ltd

In-vitro diagnostics – immunological products

PDF2MB

  • 10.15

Urgent Field Safety Notice for Cardiac Pipettes by Roche Diagnostics GmbH

In-vitro diagnostics – equipment / products for clinical chemistry

PDF368KB

  • 10.15

Urgent Field Safety Notice for FTD Cytomegalovirus, FTD Epstein-Barr virus by Fast-Track Diagnostics S.a.r.l.

In-vitro diagnostics – microbiological products

PDF132KB

  • 10.15

Urgent Field Safety Notice for BÜHLMANN GanglioCombiTM MAG ELISA by Bühlmann Laboratories AG

In-vitro diagnostics – immunological products

PDF161KB

  • 10.15

Urgent Field Safety Notice for VITROS Chemistry Products Cl- & K++ Slides by Ortho Clinical Diagnostics Inc

In-vitro diagnostics – equipment / products for clinical chemistry

PDF410KB

  • 10.15

Urgent Field Safety Notice for Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE by Axis-Shield Diagnostics Limited

In-vitro diagnostics – equipment / products for clinical chemistry

PDF438KB

  • 10.15

Urgent Field Safety Notice for iChemVELOCITY Urine Chemistry Strips by Beckman Coulter Ireland Inc.

In-vitro diagnostics – equipment / products for clinical chemistry

PDF85KB

  • 10.15

Urgent Field Safety Notice for NEOonsite by NEO New Oncology GmbH

In-vitro diagnostics – instruments, apparatuses and systems

PDF106KB

  • 10.15

Urgent Field Safety Notice for Plum and Sapphire s.t. by ICU Medical, Inc., TR

Injections / Infusions / Transfusions / Dialysis – infusion technology

PDF204KB

  • 10.15

Urgent Field Safety Notice for LeMaitre Aortic Occlusion Catheter by LeMaitre Vascular, Inc.

Injections / Infusions / Transfusions / Dialysis – catheters

PDF187KB

  • 10.14

Urgent Field Safety Notice for CareLink 2090 Programmer, CareLink Encore 2990 Programmer, and CareLink SmartSync Device Manager by Medtronic Inc

Active implantable medical devices – defibrillators

PDF114KB

  • 10.14

Urgent Field Safety Notice for MESA Rail Cutter by Stryker Spine – Leesburg

Medical instruments for use in humans – bone surgery

PDF132KB

  • 10.11

Urgent Field Safety Notice for Forte, Forte Jetstream AZ, Forte Jetstream, Diamon by Philips Medical Systems (CLE), Inc.

Radiological technology – equipment for nuclear medical functional and localisation diagnostics

PDF371KB

  • 10.11

Urgent Field Safety Notice for Cardiosave, CS100,CS300 Intra-Aortic Balloon Pumps by Datascope Corp., Patient Monitoring Division

Surgical equipment/ Anaesthesia – surgical equipment

PDF166KB

  • 10.11

Urgent Field Safety Notice for Shuttle Discovery by medifab Ltd

Orthopaedic / Rehabilitation technology – mobility aids

PDF988KB

  • 10.10

Urgent Field Safety Notice for SCFE DRIVER KNOB SUBASSY by Pega Medical, Inc.

Medical instruments for use in humans – bone surgery

PDF505KB

  • 10.10

Urgent Field Safety Notice for Agilon Schraube M5 by implantcast GmbH

Non-active implants – bone surgery

PDF170KB

  • 10.10

Urgent Field Safety Notice for NUBIC by Signus Medizintechnik GmbH

Non-active implants – bone surgery

PDF2MB

  • 10.09

Urgent Field Safety Notice for BardPort, X-Port and Groshong by Bard Access Systems Division (BASD)

Non-active implants – special implants

PDF210KB

  • 10.08

Urgent Field Safety Notice for HandyVac, Guedel Airways, Universal Connector, Exchange bags for UnoMeter 500 by ConvaTec Limited Deeside

Injections / Infusions / Transfusions / Dialysis – drainages and suction systems

PDF776KB

  • 10.08

Urgent Field Safety Notice for S.-3t & S.-3t Transesophageal (TEE) Transducers by Philips Medical Systems – Ultrasound

Ultrasonics – ultrasonic diagnostic equipment

PDF85KB

  • 10.07

Urgent Field Safety Notice for VNS Therapy SenTiva Generator by LivaNova, Inc

Active implantable medical devices – biostimulators

PDF94KB

  • 10.07

Urgent Field Safety Notice for ECHELON FLEX ENDOPATH 60mm Staplers by Ethicon Endo-Surgery, LLC.

Medical instruments for use in humans – general instruments

PDF301KB

  • 10.07

Urgent Field Safety Notice for Measuring impactor by Mathys AG Bettlach

Medical instruments for use in humans – bone surgery

PDF135KB

  • 10.04

Urgent Field Safety Notice for Carat II Pro by Hoffrichter GmbH (Servona Gruppe)

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF3MB

  • 10.04

Urgent Field Safety Notice for SCORE tibial baseplate for mobile bearing insert by Amplitude S.A.S.

Non-active implants – bone surgery

PDF724KB

  • 10.04

Urgent Field Safety Notice for Domiflex, elektr. Pflegebett by Hermann Bock GmbH

General equipment for medical treatment – furnishings

PDF477KB

  • 10.04

Urgent Field Safety Notice for EZ-IO Needle + Stabilizer KIT by Vidacare Corporation

Injections / Infusions / Transfusions / Dialysis – syringes and cannulas

PDF143KB

  • 10.02

Urgent Field Safety Notice for LQD by Medoderm GmbH

Dressings / Pads – bandages

PDF1MB

  • 10.02

Urgent Field Safety Notice for LOQTEQ Distal Laterale Femurplatte PP by aap Implantate AG

Non-active implants – bone surgery

PDF3MB

  • 10.02

Urgent Field Safety Notice for Leyla Spannarm by Lawton GmbH & Co. KG

Medical instruments for use in humans – neurosurgery

PDF2MB

  • 10.02

Urgent Field Safety Notice for Patient Data Manager by Brainlab AG

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

PDF127KB

  • 10.01

Urgent Field Safety Notice for GentleCool Pro Cryogen Canister by Candela Corporation

Optics / Precision engineering – laser technology

PDF265KB

  • 10.01

Urgent Field Safety Notice for Quart Arterial Filter by Maquet Cardiopulmonary AG

Injections / Infusions / Transfusions / Dialysis – filters

PDF2MB

 

Швейцарія

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

0.12.2019

Datex-Ohmeda Inc.

Giraffe OmniBed
Model: see FSN

Giraffe OmniBed Carestation
Model: see FSN

Giraffe Incubator Carestation
Model: see FSN

Giraffe Incubator
Model: see FSN

MD: Conventional infant incubator

MD: Conventional infant incubator

MD: Conventional infant incubator

MD: Conventional infant incubator

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

Vk_20191223_30

30.12.2019

Medartis AG

2.5 Trilock Screw 14mm, HD7
Model: A-5750.14/1S
Lot: 17169656, 18190766, 19194557, 19200335

MD: Orthopaedic bone screw, non-bioabsorbable, sterile

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

Vk_20191220_07

20.12.2019 

(Updated 30.12.2019)

Medtronic (Schweiz) AG

POLYSORB suture
Model: CL915; CL914; CL923; CL925; UL203; SL5690; CL461; CL537; CL811; CL815; CL885; CL911; CL953; GL123; GL124; GL228; GL323; GLS322; L1742K; L2752K; SL1625G; SL5679; SL654; UL877; UL878
Lot: See appendix of FSN

Biosyn Suture
Model: UM201
Lot: See appendix of FSN

MD: Polyester suture, bioabsorbable, multifilament

MD: Polyester suture, bioabsorbable, monofilament

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

Vk_20191219_01

30.12.2019

Mavidon Medical Products

LemonPrep, PediaPrep, Wave Prep, Cardio Prep
Model: Tubes and Single Use Cups
Lot: all

MD: Electrode conductive medium

EN-1

Vk_20191203_06

27.12.2019

RaySearch Laboratories AB

RayStation
Model: see FSN
Lot: see FSN

MD: Radiation therapy software

EN-1

Vk_20191227_10

27.12.2019

Integra LifeSciences

IDRT – Single Layer and IDRT TS
Model: 62021; 82021; 84051; 88101
Lot: See FSN

MD: Skin regeneration template, human-/animal-derived

DE-1
FR-1

Vk_20191227_05

27.12.2019

GE Healthcare

Centricity Universal Viewer
SW-Version: 6.0

MD: Medical image management system

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

Vk_20191223_46

27.12.2019

W.L. Gore & Associates

GORE EXCLUDER AAA Endoprosthesis
Model: See attachment

GORE EXCLUDER Iliac Branch Endoprosthesis
Model: See attachment

MD: Abdominal aorta endovascular stent-graft

MD: Iliac Branch endovascular stent-graft

EN-1

Vk_20191219_26

17.12.2019 

(Updated 27.12.2019)

Synthes GmbH

Sterile Screw implants packed in Sterile Tubes
Model: size M
Lot: part numbers ending in suffix TS

MD: Orthopaedic bone screw, non-bioabsorbable, sterile

DE-1
FR-1
IT-1

Vk_20191213_06

23.12.2019

Karl Storz Endoskope SE und Co. KG

Insufflation Tubing Set, with gas filter
Model: 030247-10, 031123-10, 031200-03, 031200-10, 031222-10, 031322-10, 031432-10, 031532-10, 031622-10
Lot: see FSN

MD: Endoscopic insufflation tubing set, single-use

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

Vk_20191223_41

20.12.2019

Fast-Track Diagnostics S.a.r.l.

FTD Respiratory pathogens 21
Model: FTD-2-32, FTD-2-64
Lot: all lots

IVD: Multiple respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

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

Vk_20191219_21

20.12.2019

Leonhard Lang GmbH

GS defibrillation electrodes
Model: corPatch easy 04324.3
Lot: 190711-3993

MD: Electrodes, Cardiac, External Defibrillator

DE-1
EN-1

Vk_20191219_20

20.12.2019

Fresenius Kabi (Schweiz) AG

PatientOnLine
Model: F989951, F989901
S/N: All Software with Version 6.2
SW-Version: Version 6.2

MD: Nephrology information system application software

EN-1

Vk_20191218_14

20.12.2019

Medtronic Sofamor Danek USA, Inc.

AsterX Expandable Corpectomy System
Model: see FSN
Lot: All

MD: Vertebral body prosthesis, non-sterile

EN-1

Vk_20191218_09

20.12.2019

Carestream Health Inc

Carestream DRX-Evolution and DRX-Evolution Plus

MD: Stationary basic diagnostic x-ray system, digital

DE-1
FR-1

Vk_20191217_14

20.12.2019

VitreQ B.V.

VitreQ
Model: Multiple
Lot: all

MD: Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

DE-1
FR-1
IT-1

Vk_20191217_12

20.12.2019

Abbott Diagnostics Technologies AS

NycoCard D-Dimer
Model: 1116081, 1116082
Lot: see FSN

IVD: D-dimer IVD, reagent

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

Vk_20191211_03

20.12.2019

RAL DIAGNOSTICS

Giemsa Solution for SP Automated System
Model: 75030SX1000
Lot: I88021 exp.20.05.2021; I97523 exp. 03.06.2021; I63818 exp. 20.05.2021

IVD: Biological stain IVD

EN-1

Vk_20191211_01

18.12.2019 

(Updated 20.12.2019)

Morcher GmbH

EYEJET CTR
Model: Typ 13 right, Typ 13A right, Typ 13B right
Lot: BKADBC
S/N: 2540604-2541803

MD: Capsular tension ring

DE-1
EN-1

Vk_20191206_21

20.12.2019

CAIR LGL

Naso-duodenal feeding tube
Model: NCE2..G

MD: Nasoenteral tube

DE-1
FR-1
IT-1

Vk_20191204_14

20.12.2019

Laboratoires ANIOS (ECOLAB)

ANIOSYME DD1
Lot: B28123S

MD: Medical device disinfectant

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

Vk_20191120_11

19.12.2019

Datex-Ohmeda, Inc (GE Healthcare)

Carestation 620 A1 / 650 A1 / 650c A1
S/N: see fsn

MD: Anaesthesia workstation, general-purpose

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

Vk_20191218_05

17.12.2019 

(Updated 19.12.2019)

Intuitive Surgical, Inc

Endoscope and Camera Head Sterilization Tray
Model: 400498-02, 400499-03; 8mm
Lot: all

MD: Instrument tray

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

Vk_20191213_10

19.12.2019

Eppendorf AG

Centrifuge 5910 R
Model: see FSN
Lot: see FSN

IVD: Aliquoters – Sorters – Centrifuges – Decappers – Recappers (SP)

DE-1
FR-1
EN-1

Vk_20191213_01

19.12.2019

Homoth Medizinelektronik GmbH & Co.KG

Air Calorisator
Model: 80-1110
Lot: see FSN
SW-Version: 3.0x

MD: Caloric irrigation unit

DE-1
EN-1

Vk_20191212_08

19.12.2019

Ulrich AG

Schulterhebel Darrach
Model: U40-576-00
Lot: AE106263

MD: Bone lever/elevator

DE-1

Vk_20191209_08

30.04.2019 

(Updated 19.12.2019)

Maquet SAS

VOLISTA
Model: STANDOP & TRIOP

MD: Operating light

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

Vk_20190424_08

18.12.2019

B. Braun Melsungen AG

Original Perfusor Line
Model: 8726019
Lot: 61676305

MD: Intravenous administration tubing extension set

DE-1

Vk_20191216_15

18.12.2019

Fast-Track Diagnostics S.a.r.l.

FTD CE-IVD Kits
Model: see FSN
Lot: see FSN

IVD: IVD kits for the detection of various pathogens

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

Vk_20191216_14

28.10.2019 

(Updated 18.12.2019)

Stryker Endoscopy

PKG,STRYKEFLOW ELECROCAUTERY P
Model: 0250070450, 0250070460
Lot: see FSN

MD: Universal hand-controlled electrosurgical diathermy system conducting unit, reusable

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

Vk_20191021_02

17.12.2019

Maquet SAS

Sterilizable handle “Hanaulux”
Model: ARD568303903; ARD568335999; ARD568350904
Lot: 50025; 40091; 40033; 50014
S/N: All products manufactured between October 2007 and November 2017

MD: Operating light

EN-1

Vk_20191212_13

17.12.2019

Randox Laboratories Ltd

Liquid Chemistry Control Premium Plus
Model: LAE4217
Lot: 1021UE

IVD: Multiple clinical chemistry analyte IVD, control

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

Vk_20191212_01

11.12.2019 

(Updated 16.12.2019)

ResMed Ltd.

Stellar
Model: 100, 150; 24141, 24142, 24143, 24144, 24145, 24151, 24152, 24153, 24154, 24155
S/N: 20160123307 to 22171057208

MD: Portable electric ventilator

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

Vk_20191205_17

16.12.2019

Gebrüder Martin GmbH & Co. KG

Skalpellklinge
Model: see FSN
Lot: see FSN

MD: Scalpel blade, single-use

DE-1
FR-1
IT-1

Vk_20191205_09

16.12.2019

Stryker Trauma Kiel

Delta Strike Plate IMN Instruments
Model: 23510050
Lot: all lots

MD: Bone nail driver

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

Vk_20191205_03

10.12.2019 

(Updated 13.12.2019)

ViewRay Inc.

Stereotactic radiotherapy/MRI System
Model: MRIdian Linac System; 10000, 20000
S/N: ALL
SW-Version: 4.x

MD: Stereotactic teletherapy radionuclide system, MRI-imaging

DE-1
EN-1

Vk_20191204_08

05.12.2019 

(Updated 12.12.2019)

Elekta Limited

Elekta Unity

MD: Linear accelerator system

FR-1
EN-1

Vk_20191129_21

27.11.2019 

(Updated 12.12.2019)

Edwards Lifesciences LLC

HemoSphere Oximetry Cable
Model: HEMOXSC100
Lot: N/A
SW-Version: N/A

MD: Single-patient physiologic monitoring system

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

Vk_20191122_02

21.11.2019 

(Updated 12.12.2019)

Philips Goldway (Shenzhen) Industrial Inc.

Efficia DFM 100
Model: 866199
S/N: See UAL86100207

MD: Rechargeable professional automated external defibrillator

DE-1 customer
DE-1 distributor
DE-2 customer
DE-2 distributor
FR-1 customer
FR-2 customer
IT-1 customer
IT-2 customer
EN-1 customer
EN-1 distributor
EN-2 customer
EN-2 distributor

Vk_20191118_07

11.12.2019

GE Medical Systems

SIGNA PET/MR

Discovery MR750w 3.0T, Discovery MR750 3.0T, Optima MR450w 1.5T, Discovery MR450 1.5T, SIGNA Architect, SIGNA Artist

MD: PET/MRI system

MD: Full-body MRI system, superconducting magnet

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

Vk_20191209_02

11.12.2019

Biomet Orthopaedics Switzerland GmbH

OPTIPAC-S 40 REFOBACIN BONE CEMENT R
Model: 4710500394-1
Lot: All lot numbers

OPTIPAC-S 60 REFOBACIN BONE CEMENT R
Model: 4710500396-1
Lot: All lot numbers

OPTIPAC-S 80 REFOBACIN BONE CEMENT R
Model: 4710500398-1
Lot: All lot numbers

OPTIPAC SOFTPAC HIPSET
Model: 4740500394-1
Lot: All lot numbers

MD: Orthopaedic cement, medicated

MD: Orthopaedic cement, medicated

MD: Orthopaedic cement, medicated

MD: Orthopaedic cement, medicated

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

Vk_20191122_04

10.12.2019

Respironics Inc.

Trilogy Evo
Model: see FSN
S/N: see FSN

Garbin Evo
Model: see FSN
S/N: see FSN

LifeVent Evo2
Model: see FSN
S/N: see FSN

MD: Portable electric ventilator

MD: Portable electric ventilator

MD: Portable electric ventilator

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

Vk_20191205_21

10.12.2019

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_20191205_07

10.12.2019

MicroVention Inc.

MicroPlex and HydroCoil Embolic System
Model: see FSN
Lot: see FSN

MD: Neurovascular embolization coil

DE-1
FR-1
IT-1

Vk_20191204_03

10.12.2019

Edwards Lifesciences LLC

Quickdraw – Peripheral venous access cannula
Model: QD22, QD25
Lot: see FSN

MD: Cardiopulmonary bypass cannula, venous

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

Vk_20191204_02

10.12.2019

3M Deutschland GmbH, Health Care Business

Durapore Advanced Surgical Tape
Model: 1590-0, 1590-1, 1590-2, 1590-3, 1591-0, 1591-1, 1591-2, 1591-3, 1590S-1, 1590S-2
Lot: All

MD: Hypoallergenic skin adhesive tape

DE-1
EN-1

Vk_20191203_10

10.12.2019

Cristalens Industrie

Calculation Software for Artis PL E Toric
SW-Version: 3.0.1

MD: Posterior-chamber intraocular lens, pseudophakic

DE-1

Vk_20191129_14

10.12.2019

FH ORTHOPEDICS INC

Cannulated TLS DRILL BIT Ø 2.5
Model: 254 537, 253 165, 251 830, 250 102, 250 101, 251 831
Lot: All lots

MD: Cannulated TLS DRILL BIT

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

Vk_20191125_12

26.11.2019 

(Updated 10.12.2019)

Schiller AG

Tempus LS
Model: 3.940590
S/N: see FSN

MD: Physiologic-monitoring defibrillation system

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

Vk_20191121_14

04.12.2019 

(Updated 09.12.2019)

bioMerieux SA

VIDAS Varicella-Zoster lgG
Model: VIDAS VZG, 30217
Lot: 1007410330, 1007393380

IVD: Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

DE-1
FR-1
EN-1

Vk_20191129_13

09.12.2019

SLE Limited

SLE6000 Infant Ventilator
Model: Z6000
S/N: 6010100037, 6010100038, 6010100039, 6010100056, 6010100057, 6010100058, 6010100059, 6010100060, 6010100061, 6010100097

MD: Neonatal intensive-care ventilator

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

Vk_20191128_06

09.12.2019

Medtronic Navigation Inc.

O-arm O2 Imaging System
Model: BI-700-02000 O-arm O2 Base
S/N: See FSN

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

DE-1
IT-1
EN-1

Vk_20191126_02

09.12.2019

W.L. Gore & Associates

GORE DrySeal Flex Introducer Sheath
Model: 14Fr, 33cm; DSF1433
S/N: 21060843 – 21060938, 21061596 – 21061691, 21077174 – 21077269, 21077274 – 21077369, 21077385 – 21077480, 21077549 – 21077644

MD: Haemostasis valve

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

Vk_20191118_24

28.11.2019 

(Updated 06.12.2019)

Medtronic MiniMed

Medtronic MiniMed 640G Insulin Pump
Model: MMT-1711, MMT-1712

MiniMed 670G Insulin Pump
Model: MMT-1780, MMT-1781, MMT-1782

MD: Ambulatory insulin infusion pump, electronic

MD: Ambulatory insulin infusion pump, electronic

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

Vk_20191125_03

14.11.2019 

(Updated 06.12.2019)

Philips Medical Systems

Heartstart XL Defibrillator/ Monitor
Model: 861290

MD: Rechargeable professional automated external defibrillator

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

Vk_20191029_09

05.12.2019

Thoratec (Abbott)

Heartmate III
Model: MPU: 107758, HM3 LVAS Kit: 106524INT, 106524;MPU catalogue #107758, HM3 LVAS #106524INT and #106524
S/N: All Serial Numbers of MPU catalogue #107758 and HM3 LVAS #106524INT and #106524
SW-Version: N/A

AIMD: Implantable ventricular circulatory assist system

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

Vk_20191203_01

05.12.2019

AMO Ireland

Healon GV PRO
Model: 10240014
Lot: see FSN

MD: Vitreous/aqueous humour replacement medium, intraoperative

DE-1
FR-1
EN-1

Vk_20191129_15

22.11.2019 

(Updated 05.12.2019)

Laboratoires Anios

SURFA SAFE PREMIUM
Model: 2419326, 2419544, 2419544HD
Lot: see Annex II of FSN

MD: Medical device disinfectant

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

Vk_20191111_11

04.12.2019

nal von minden GmbH

NADAL hCG pregnancy test
Model: 141000
Lot: 169757

IVD: HCG – RT & POC

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

Vk_20191203_02

04.12.2019

Smith & Nephew, Inc.

PROFIX 750 GRAMS Mallet
Model: 71512452
Lot: all

MD: Surgical mallet

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

Vk_20191202_05

04.12.2019

Siemens Healthcare GmbH; Business Area Advanced Therapies

Cios Alpha
Model: Material number: 10308191

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

DE-1
FR-1
EN-1

Vk_20191128_09

03.12.2019

MicroVention Inc.

Detachable Azur Peripheral Coil System
Model: See FSN
Lot: See FSN

MD: Non-neurovascular embolization implant, non-bioabsorbable

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

Vk_20191202_06

03.12.2019

Dexcom, lnc.

Dexcom G6 iOS CGM App
Model: SW11585, SW11586
SW-Version: All prior to 1.5.4

MD: Percutaneous glucose monitoring system

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

Vk_20191126_08

02.12.2019

Medela AG

Invia Foam Dressing Kit with FitPad X-Large
Model: 087.6224
Lot: 17110012731, 17110022736, 17120012746, 18010012767, 18070012913, 18090012960, 18110013046

MD: Negative-pressure wound therapy system dressing set

DE-1
EN-1

Vk_20191121_13

26.11.2019 

(Updated 02.12.2019)

Medtronic Inc.

Refill Kit, Catheter Access Port Kit
Model: 8553, 8555, 8543
Lot: All

AIMD: Neurosurgical procedure kit, non-medicated, single-use

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

Vk_20191120_10

20.11.2019 

(Updated 02.12.2019)

EIT Emerging Implant Technologies GmbH

EIT Implants (Cervical, PLIF, TLIF)
Lot: see FSN
S/N: see FSN

MD: Metallic spinal fusion cage, sterile

DE-1
EN-1

Vk_20191118_20

02.12.2019

Biomet Orthopedics

Vanguard XP Tibial Tray
Model: 195245, 195246, 195247, 195248, 195249, 195250,

MD: Uncoated knee tibia/insert prosthesis

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

Vk_20190830_19

29.11.2019

Stryker GmbH

Sliding Core UHMPWE
Model: see attachment: PFA 2173330 affected articles V1
Lot: all

MD: Ankle prosthesis bearing

DE-1
FR-1
IT-1

Vk_20191024_11

28.11.2019

IVF HARTMANN AG

Druckverband sterile
Model: 831 273
Lot: 900127418, 90749932

MD: First aid gauze/bandage

DE-1
FR-1
IT-1

Vk_20191126_09

28.11.2019

Elekta, Inc.

Monaco RTP System
Model: N/A
Lot: N/A
S/N: N/A
SW-Version: Version 5.40 and higher

MD: Radiation therapy software

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

Vk_20191120_17

27.11.2019

Telemis

Telemis-Medical
SW-Version: All versions up to 4.90-u00.5

MD: Picture archiving and communication system

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

Vk_20191120_14

19.11.2019 

(Updated 27.11.2019)

Olympus Medical Systems Corp.

OLYMPUS DUODENOVIDEOSCOPES & DUODENOFIBERSCOPES
Model: TJF-160R, TJF-140R, JF-140R, TJF-240, JF-240, JF-1T40, JF-TE3
S/N: see FSN

MD: Flexible video duodenoscope, reusable; Flexible fibreoptic duodenoscope

DE-1
FR-1
EN-1

Vk_20191115_26

26.11.2019

Covidien LLC

Valleylab LS10
Model: VLLS10GEN
SW-Version: All

Valleylab FX8
Model: VLFX8GEN
SW-Version: 1.1 and earlier

Valleylab FT10
Model: VLFT10GEN
SW-Version: 4.0.0 and earlier, Valleylab Exchange (VLEX) Client SW versions 3.4 and earlier

MD: Electrosurgical system generator

MD: Electrosurgical system generator

MD: Electrosurgical system generator

DE-2
FR-2
IT-2

Vk_20191125_01

26.11.2019

GE Healthcare Finland Oy

CARESCAPE Respiratory Module

MD: Patient monitoring system module, multiple-gas

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

Vk_20191120_18

26.11.2019

TomTec Imaging Systems

TOMTEC-ARENA
Model: TTA2
SW-Version: see FSN

MD: Imaging processing software

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

Vk_20191112_12

25.11.2019

Edwards Lifesciences LLC

Cardioband Mitral Reconstruction System
Model: VSU04001

Cardioband Tricuspid Reconstruction System
Model: VSU07001

MD: Mitral/tricuspid annuloplasty ring

MD: Mitral/tricuspid annuloplasty ring

DE-1
FR-1
IT-1

Vk_20191114_21

20.11.2019 

(Updated 25.11.2019)

Stago

System Control N + P, STA – System Control N + P, STA – Quali-Clot I, STA – Quali-Clot II
Model: 00617, 00678, 00982, 00988

STA – UNICALIBRATOR
Model: 00675

UNICALIBRATOR
Model: 00625

STA – DEFICIENT VIII
Model: 00725

STA – DEFICIENT IX
Model: 00724

IVD: Haemostasis Reagents (Coagulation)

IVD: Multiple coagulation factor IVD, calibrator

IVD: Multiple coagulation factor IVD, calibrator

IVD: Haemostasis Reagents (Coagulation)

IVD: Haemostasis Reagents (Coagulation)

DE-1
EN-1

Vk_20191113_12

21.11.2019 

(Updated 25.11.2019)

GGT Holding BV

Telefunken / HeartReset
Model: HR1 /FA1
Lot: 8718481270XX – 8718481275XX
S/N: 1629015177- 1839859023

MD: AED, automated external defibrillator

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

Vk_20191018_04

22.11.2019

Laboratoire CCD

1ml IVF and AI Syringes
Model: 1323101/7002655
Lot: see FSN

MD: General-purpose syringe, single-use

DE-1
FR-1
EN-1

Vk_20191118_14

22.11.2019

Cordis Corporation

S.M.A.R.T. stents
Model: see FSN
Lot: all
S/N: all

S.M.A.R.T. control stents
Model: see FSN
Lot: all
S/N: all

PRECISE stents
Model: see FSN
Lot: all
S/N: all

MD: Biliary stent

MD: Bare-metal biliary stent

MD: Bare-metal carotid artery stent

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

Vk_20191114_13

22.11.2019

Draeger Medical Systems, Inc.

Standalone Infinity M540 patient monitor
SW-Version: VG7.0.1,VG7.0.2

Infinity Acute Care System
SW-Version: VG7.0.1,VG7.0.2

MD: Single-patient physiologic monitoring system

MD: Single-patient physiologic monitoring system

DE-1
FR-1

Vk_20190503_10

21.11.2019

Flowonix Medical

Prometra Programmable Pump
Model: 91827; 93827
Lot: all

AIMD: Implantable intrathecal infusion pump, programmable

DE-1
FR-1
IT-1

Vk_20191115_13

20.11.2019

Elekta Nucletron B.V

Flexitron HDR – Flexitron Cobalt-60
Model: 136149 – 136005

MD: Remote-afterloading brachytherapy system

DE-1
EN-1

Vk_20191118_17

20.11.2019

Amplitude S.A.S.

Instrument set for OPTIMAL stem
Model: 2-0199963
Lot: All the batches numbers

MD: Orthopaedic prosthesis implantation instrument, reusable

FR-1
EN-1

Vk_20191106_09

20.11.2019

Cepheid AB

Xpert HIV-1 Viral Load
Model: GXHIV-VL-CE-10
Lot: all

IVD: HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT)

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

Vk_20191029_06

19.11.2019

Avanos Medical, lnc.

Halyard Closed Suction System
Model: 109382303, 109382803, 109382903, 109838302

MD: Suction system catheter, general-purpose

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

Vk_20191115_27

15.11.2019

Roche Diabetes Care GmbH

Accu-Chek Aviva / Accu-Chek Performa BGM
Lot: Not applicable
S/N: Accu-Chek Aviva II meters: between XXX05000001 and XXX06335297 or between XXX20000000 and XXX23284925 Accu-Chek Performa II meters: between XXX20000000 and XXX25525056
SW-Version: Not applicable

IVD: Home-use/point-of-care glucose analyser IVD, battery-powered

DE-1
FR-1
IT-1

Vk_20191106_29

15.11.2019

Waldemar Link GmbH & Co. KG

Standard C Cem standard / lateralized
Model: 161-500, 161-520

MD: Uncoated hip femur prosthesis, modular

DE-1_EN-1

Vk_20191105_23

15.11.2019

Waldemar Link GmbH & Co. KG

Standard C Cem standard / lateralized
Model: 161-501, 161-502, 161-521, 161-522
Lot: ALL

MD: Uncoated hip femur prosthesis, modular

DE-1_EN-1

Vk_20191105_20

24.10.2019 

(Updated 15.11.2019)

DiaMed GmbH

IH-QC1
Model: 08710; 009321
Lot: 08710.42.1

IVD: Multiple immunohaematology test IVD, control

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

Vk_20191017_06

02.04.2019 

(Updated 15.11.2019)

Medtronic Inc.

Activa Clinician Programmer Application
Model: A610
S/N: All
SW-Version: 1.0.3470

AIMD: Multiple active implantable device programmer

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

Vk_20190402_02

28.03.2019 

(Updated 15.11.2019)

Beckman Coulter Biomedical GmbH

DxA 5000
Model: B87352
Lot: Not applicable
S/N: All
SW-Version: 1.0.13 and 1.0.14

IVD: Specimen processing instrument IVD, automated

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

Vk_20190325_16

14.11.2019

Synthes GmbH

USS II Polyaxial 3D Head
Model: 04.607.402, 04.607.402S
Lot: See FSN
S/N: N/A

MD: Bone-screw internal spinal fixation system, non-sterile

DE-1
EN-1

Vk_20191111_09

14.11.2019

Beckman Coulter Ireland, Inc.

iChemVELOCITY Automated Urine Chemistry System
Model: 700-7176-001, 700-7177-0 700-7177-001RFB, 700-7176-001RFB
S/N: all

IVD: Urine analyser IVD, laboratory, automated

DE-1
FR-1
EN-1

Vk_20191107_07

14.11.2019

Ethicon Endo-Surgery LLC

LIGAMAX-5 5MM Endoscopic Multiple Clip Applier
Model: EL5ML
Lot: T9416M
S/N: N/A

MD: Open-surgery ligation clip applier

DE-1
FR-1

Vk_20191106_38

05.11.2019 

(Updated 14.11.2019)

Covidien LLC

Genius 2 Tympanic Thermometer
Model: 303000
Lot: n/a
S/N: see FSN
SW-Version: N/A

Genius 3 Tympanic Thermometer
Model: 303013
S/N: see FSN

MD: Infrared patient thermometer, ear

MD: Infrared patient thermometer, ear

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

Vk_20191031_02

14.11.2019

Villa Sistemi Medicali S.p.A.

Apollo
Model: 9784170013
Lot: 10080728

Apollo DRF; Juno DRF
Model: 9784220813; 9784279813; 709020
Lot: 09010569, 14041315, 10070720, 11080853, 12071035, 13031217, 13071246, 14111391, 14121406, 15051448, 15071469, 16011510, 16041528, 16091565

MD: Manual endodontic spreader

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

DE-1-Apollo
DE-1-Juno
FR-1-Apollo
FR-1-Juno
IT-1-Apollo
IT-1-Juno

Vk_20191028_07

13.11.2019

Beckman Coulter Ireland, Inc.

iChemVELOCITY Automated Urine Chemistry System
Model: 700-7176-001, 700-7177-001, B75502, B75503, 700-7087, 700-7177-001RFB, 700-7176-001RFB
S/N: All having the software versions 7.0.5 and later

iQ200 Series Urine Microscopy Analyzer
Model: 700-3345, 700-3375, 700-3325, 700-3347, 700-3326, C10683, C10684, 700-3370, 700-3320, 700-3322, 700-3340, 700-3320RFB, B48999, B48998, 700-3376, B48997, 700-3322RFB, 700-3300RFB, 700-3300, 700-3375RFB
S/N: All having the software versions 7.0.5 and later

IVD: Urine analyser IVD, laboratory, automated

IVD: Urine analyser IVD, laboratory, automated

DE-1
FR-1
EN-1

Vk_20191106_31

24.10.2019 

(Updated 13.11.2019)

Eurovema AB

Euroflex work chairs with Forma chassis
Model: 80XXXXXX, 241-XX, 242-XX, 291-XX, 292-XX, 841-XX, 891-XX

MD: Wheelchair

FR-1
EN-1

Vk_20191002_11

12.11.2019

USF Healthcare SA

UNISEPTA FOAM 2
Model: 2458
Lot: see Annex II

MD: Medical device disinfectant

DE-1
FR-1
EN-1

Vk_20191111_10

12.11.2019

TORNIER SAS

Aequalis Ascend Flex Shoulder System
Model: see FSN

MD: Total reverse shoulder prosthesis

DE-1
FR-1
IT-1

Vk_20191107_21

12.11.2019

GE Medical Systems Information Technologies, Inc.

ApexPro Telemetry System
SW-Version: 3.9, 4.0, 4.1, 4.2, 4.3

MD: Electrocardiography telemetric monitoring system

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

Vk_20191107_19

12.11.2019

MAQUET Cardiopulmonary GmbH

QUADROX-iD Pediatric with BIOLINE Coating
Model: 70104.7041, 70105.0330

MD: Extracorporeal membrane oxygenator

DE-1

Vk_20191028_01

11.11.2019

Medacta International SA

Humeral Anatomical Metaphysis
Model: From 04.01.0023 to 04.01.0055
Lot: From 184523 to 184555, From 1901136 to 1901148, and 1904909

MD: Total shoulder prosthesis

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

Vk_20191104_06

11.11.2019

Medtronic Navigation Inc.

Passive Biopsy Needle Kit
Model: 9733068, 9731754
Lot: 066503918A, 066513519A, 066529218A, 066535518A, 066503919, 066513519C, 066531018, 066512319A, 066513519E, 066531018A, 066512319C, 066529218, 066535518, 0009665221, 0009709452, 0009960538

MD: Brain biopsy procedure kit

DE-1
FR-1
EN-1

Vk_20191031_10

11.11.2019

Roche Diagnostics GmbH

Elecsys Troponin-T hs STAT
Model: see FSN
Lot: see FSN

Elecsys Troponin T hs
Model: see FSN
Lot: see FSN

IVD: Troponin T IVD, kit, enzyme immunoassay (EIA)

IVD: Troponin T IVD, kit, enzyme immunoassay (EIA)

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

Vk_20191031_01

11.11.2019

Radiometer Medical ApS

Cleaning Solution for AQT90 FLEX
Model: 905-843
Lot: 0265; 0266

IVD: Fluorescent immunoassay analyser IVD, laboratory, automated

FR-1
EN-1

Vk_20191030_24

05.11.2019 

(Updated 11.11.2019)

BioMérieux Inc.

BacT/ALERT VIRTUO Microbial Detection System
Model: 411660, 411661 (CH) 419947, 423444 (not CH)
S/N: All serial numbers
SW-Version: R2.0

IVD: Blood culture analyser IVD, automated

DE-1
FR-1
EN-1

Vk_20191030_16

11.11.2019

Ulrich AG

Sattelhaken Fritsch
Model: U20-414-24
Lot: AE104370

MD: Wundretraktor, halbtief/tief

DE-1

Vk_20191030_11

29.10.2019 

(Updated 11.11.2019)

DEAS Srl

Deas
Model: 04314 NS, 04314
Lot: see fsn

MD: Autofeed Humidification Chamber

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

Vk_20191022_11

06.11.2019

Fast-Track Diagnostics S.a.r.l.

FTD BKV
Model: FTD-55.1-32; FTD-55.1-64
Lot: all

IVD: Multiple immunocompromised host infection-associated virus nucleic acid IVD, nucleic acid technique (NAT)

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

Vk_20191104_07

06.11.2019

imtmedical ag

Bellavista
Model: bellavista 1000, 1000 NEO & 1000e 17.3″; 301.100.000, 301.100.060, 301.100.100, 301.100.200
S/N: see FSN

MD: Neonatal/adult intensive-care ventilator

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

Vk_20191001_01

06.11.2019

imtmedical ag

Bellavista
Model: bellavista XX, bellavista 950; 301.100.000, 301.100.030, 301.100.060, 301.100.100, 301.100.200, 950.100.000
S/N: MB100100 and higher

MD: Neonatal/adult intensive-care ventilator

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

Vk_20190909_01

05.11.2019

Teleflex Medical

Ruschcare TracFlex Plus Phonation Set, Cuffed
Model: see FSN
Lot: see FSN

Rusch TracFlex Plus Phonation Set, Cuffed
Model: see FSN
Lot: see FSN

MD: Basic tracheostomy tube, single-use

MD: Basic tracheostomy tube, single-use

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

Vk_20191101_19

05.11.2019

Cook Incorporated

Torcon NB Advantage Catheter
Model: See FSN
Lot: 9700385, 9708139, 9709328, 9710402, 9713001, 9713002, 9713048, 9714540, 9726996, 9890919, 9900974, 9908469, 9911359, 9936124, NS9701376, NS9720276, NS9906241

MD: Angiographic catheter, single-use

DE-1
FR-1
EN-1

Vk_20191101_04

05.11.2019

Synedra Information Technologies GmbH

synedra View
SW-Version: 17.x (“Poseidon”), 18.x (“Apollon”), 19.x. (“Zephyr”)

MD: Radiology picture archiving and communication system

DE-1
FR-1
EN-1

Vk_20191030_15

05.11.2019

bioMérieux

Cetrimide Agar
Model: 43565
Lot: 1007530990

IVD: Differential/selective agar culture medium IVD

DE-1
FR-1
EN-1

Vk_20191029_17

04.11.2019

Philips Healthcare – Andover

HeartStart XL+ Defibrillator/Monitor
Model: 861290

MD: Rechargeable professional automated external defibrillator

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

Vk_20191030_08

04.11.2019

Chromsystems Instruments & Chemicals GmbH

6PLUS1 Multilevel Saliva Calibrator Set
Model: 73039
Lot: 1517; 1518

MassChrom Cortisol, Cortisone Saliva Control Level I
Model: 0349
Lot: 1517; 1518

MassChrom® Cortisol, Cortisone Saliva Control Level II
Model: 0350
Lot: 1517, 1518

IVD: Cortisol

IVD: Cortisol

IVD: Cortisol

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

Vk_20191024_07

04.11.2019

Haemonetics Corporation

Cell saver
Model: 00260-00, 00261-00, 00263-00, 0263A-00, 00265-00, 0260F-00, 00265F-00, CSE-FP-125V, CSE-FP-225V, CSE-FP-225F, CSE-P-125, CSE-P-225

MD: Blood-processing autotransfusion system set

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

Vk_20191023_08

25.09.2019 

(Updated 04.11.2019)

Abbott

Level Sensor, Bulk Solution
Model: 04S68-02

Accessory kit, Alinity i
Model: 03R66-03

Accessory kit #2, Alinity c
Model: 03R69-03, 03R69-04

IVD: Chemiluminescent immunoassay analyser IVD, automated

IVD: Chemiluminescent immunoassay analyser IVD, automated

IVD: Chemiluminescent immunoassay analyser IVD, automated

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

Vk_20190918_03

07.08.2019 

(Updated 04.11.2019)

Med-Dyne

Gold Cup electrodes
Model: See FSN
Lot: See FSN

Snap Leadwire
Model: See FSN
Lot: See FSN

MD: Analytical non-scalp cutaneous electrode

MD: Analytical non-scalp cutaneous electrode

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

Vk_20190802_28

01.11.2019

Becton Dickinson GmbH

BD CHROMagar Orientation Medium
Model: 254107; 257481
Lot: 9197107; 9197107

IVD: Hektoen enteric agar culture medium IVD

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

Vk_20191101_17

29.10.2019 

(Updated 01.11.2019)

Integra LifeSciences (Ireland) Ltd.

CUSA Clarity Console
Model: C7000
S/N: All

MD: Soft-tissue ultrasonic surgical system

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

Vk_20191028_03

01.11.2019

Abbott

Alinity c Carbon Dioxide Reagent Kit
Model: 07P7230; 07P7220
Lot: 54449UQ03; 54454UQ03

IVD: Carbon dioxide (CO2) IVD, kit, spectrophotometry

DE-1
EN-1

Vk_20191025_11

30.10.2019 

(Updated 01.11.2019)

Edwards Lifesciences LLC

EZ Glide Aortic Cannula
Model: EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA, EZF24A, EZF24TA, EZS21A, EZS21TA, EZS24A, EZS24TA
Lot: See FSN

MD: Cardiopulmonary bypass cannula, arterial

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

Vk_20191023_02

10.10.2019 

(Updated 01.11.2019)

GN Hearing NS

Resound
Model: see FSN
Lot: see FSN
SW-Version: 2.4.0 and 2.4.1

MD: Behind-the-Ear hearing aids and In-the-Ear hearing aids

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

Vk_20190923_10

31.10.2019

Hermann Bock GmbH

Limoss Typ MD200
Model: 450792/800.00453

MD: double drives for nursing care beds

DE-EN-1
FR-EN-1

Vk_20191024_09

31.10.2019

Beckman Coulter

MicroScan WalkAway Instrument
Model: see FSN
S/N: see FSN

IVD: Microorganism identification/antimicrobial-susceptibility analyser IVD, automated

DE-1
EN-1

Vk_20191022_10

30.10.2019

Boston Scientific Corporation

Emerge Monorail (MR) PTCA Dilatation Catheters
Model: see FSN
Lot: see FSN

NC Emerge Monorail PTCA Dilatation Catheters
Model: see FSN
Lot: see FSN

Guidezilla II Guide Extension Catheters
Model: see FSN
Lot: see FSN

MD: Coronary angioplasty balloon catheter, basic

MD: Coronary angioplasty balloon catheter, basic

MD: Vascular guide-catheter, single-use

DE-1
FR-1
EN-1

Vk_20191029_08

29.10.2019 

(Updated 30.10.2019)

Allergan Inc.

XEN Glaucoma Treatment System
Model: XEN 45, 5507-001
Lot: 61566, 61580, 61626, 61642, 61685, 61846, 61847, 61955, 61996, 62008, 62031, 62053, 62066, 62108, 62130, 62263, 62297, 62318, 62380, 62636, 62678, 62719, 62749

MD: Glaucoma shunt

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

Vk_20191023_11

30.10.2019

Fast-Track Diagnostics S.a.r.l.

FTD Hepatitis E RNA
Model: FTD-67.1-32, FTD-67.1-64
Lot: all

IVD: Hepatitis E virus nucleic acid IVD, kit, nucleic acid technique (NAT)

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

Vk_20191022_16

30.10.2019

Siemens Healthcare Diagnostics Inc

Atellica CH 930 Analyzer
Model: 11067000
SW-Version: V1.19.x and V1.20.0.

IVD: Chemiluminescent immunoassay analyser IVD, automated

DE-1
EN-1

Vk_20191022_07

30.10.2019

arcomed ag

Syramed µSP6000
Model: Chroma
S/N: Produced from June 2016 (serial number ending with xxxx1606) or production date till 09/2019

Volumed µVP7000
Model: Chroma
S/N: Production date 201907 – 201909

MD: Infusion Pumps, Multitherapy, Syringe

MD: Infusion Pumps, Multitherapy, Ambulatory

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

Vk_20191008_01

06.03.2018 

(Updated 30.10.2019)

Eurogine

ÁNCORA
Model: 01030000; 01030400; 01030200
Lot: 0114 / 0614 / 1114 / 0415 / 1115 / 0216 / 0616 / 1116 / 0217 / 0417 / 0917

NOVAPLUS T 380 Cu / NOVAPLUS T 380 Ag
Model: 01010500; 01010600; 01010700; 01020100; 01020200
Lot: 0114 / 0614 / 1114 / 0415 / 1115 / 0216 / 0616 / 1116 / 0217 / 0417 / 0917

GOLD T
Model: 01040000; 01040100; 01040200
Lot: 0114 / 0614 / 1114 / 0415 / 1115 / 0216 / 0616 / 1116 / 0217 / 0417 / 0917

MD: Intrauterine device, metal-covered

MD: Intrauterine device, metal-covered

MD: Intrauterine device, metal-covered

DE-2
DE-3
FR-2
FR-3
IT-2
IT-3
EN-1
EN-2
EN-3

Vk_20180227_10

29.10.2019

Arthrex INC

Low Profile Screw, 4.5 x 20 mm
Model: AR-8545-20
Lot: 10308261

MD: Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

DE-1

Vk_20191028_09

28.10.2019 

(Updated 29.10.2019)

Bard Peripheral Vascular

Bard® MaxCore® Disposable Core Biopsy Instrument
Model: see FSN
Lot: see FSN

MD: Mammographic stereotactic biopsy system

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

Vk_20191018_03

22.10.2019 

(Updated 29.10.2019)

ArjoHuntleigh AB

Akron Tilt Table
Model: A8652, A8652T
S/N: 508 units with serial number in a range P0151552 – P0500645

MD: Examination/treatment table, line-powered

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

Vk_20191009_04

28.10.2019 

(Updated 28.10.2019)

Roche Diabetes Care GmbH

Accu-Chek Guide
Lot: Not applicable
S/N: All Serial numbers below XXX11000001 (where “XXX” is the first 3 digits of the serial number).
SW-Version: Not applicable

IVD: Home-use/point-of-care glucose analyser IVD, battery-powered

DE-1_D
DE-1_HCP
DE-1_P
FR-1_D
FR-1_HCP
FR-1_P
IT-1_D
IT-1_HCP
IT-1_P

Vk_20191021_20

28.10.2019

Limacorporate S.p.a.

SL cementless
Model: 3515.21.003
Lot: All lot# produced starting from 3rd August 2019

SL cemented
Model: 3515.15.003
Lot: All lot# produced starting from 3rd August 2019

LOGICA MIRROR cemented
Model: 3715.07.005, 3715.07.010
Lot: All lot# produced starting from 3rd August 2019

FRIENDLY cemented
Model: 4110.07.220, 4110.07.230, 4110.07.320, 4110.07.330
Lot: All lot# produced starting from 3rd August 2019

H-MAX C cemented
Model: 4260.07.090, 4260.07.100, 4261.07.090, 4261.07.100
Lot: All lot# produced starting from 3rd August 2019

MD: Press-fit femoral stem prosthesis

MD: Uncoated femoral stem prosthesis, one-piece

MD: Uncoated femoral stem prosthesis, one-piece

MD: Uncoated femoral stem prosthesis, one-piece

MD: Uncoated femoral stem prosthesis, one-piece

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

Vk_20191015_16

25.10.2019 

(Updated 28.10.2019)

Cook Incorporated

Guardia Access – K-JETS-7019, Guardia Access Nano – K-JETS-551910
Lot: 8361746, 9502915

MD: Assisted reproduction catheter set

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

Vk_20191015_14

28.10.2019

VHMED (Nantong) Co. Ltd.

Specimen Retrieval Bag
Model: SR006
Lot: 19052001

MD: Tissue extraction bag

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

Vk_20191014_01

28.10.2019

Rocket Medical

Fetal Blood Sampling Kit
Model: R57024-00-SW

MD: Foetal blood sampling kit, scalp

DE-1

Vk_20190808_10

24.10.2019

Karl Storz Endoskope SE und Co. KG

C-MAC
Model: 8401 XX, 8403 XX
S/N: alle

MD: Video intubation laryngoscope blade

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

Vk_20191021_17

24.10.2019

bioMerieux Inc

VIDAS 3
Model: 412590

IVD: Fluorescent immunoassay analyser IVD, laboratory, automated

DE-1
FR-1
EN-1

Vk_20191021_16

15.10.2019 

(Updated 24.10.2019)

Medtronic Inc.

SynchroMed II Implantable Infusion Pump
Model: 8637-20; 8637-40
S/N: Devices with manufacturing date: 04-May-2018 to 05-Apr-2019 / expiry date: 28-Oct-2019 to 28-Sep-2020

AIMD: Implantable intrathecal infusion pump, programmable

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

Vk_20191010_04

23.10.2019

Siemens Healthcare Diagnostics Inc

Atellica IM Active-B12 (Holotranscobalamin) (AB12)
Model: 10733001
Lot: 35437023

IVD: Holotranscobalamin (holoTC) IVD, kit, chemiluminescent immunoassay

DE-1
EN-1

Vk_20191021_03

23.10.2019

Thermo Fisher Scientific Microbiology Basingstoke

ThermoScientific Oxoid Ceftazidime 256 M.I.C.E.
Model: MA0120D & F
Lot: 2423244

IVD: Bacteriology – Identification & Susceptibility Testing

EN-1

Vk_20191017_03

23.10.2019 

(Updated 23.10.2019)

Medtronic Inc.

MyCareLink Heart Mobile Application
Model: MSW003, MSW004

CareLink Programmer
Model: 2090
S/N: all

29901 EncoreTM Programmer
Model: 29901
S/N: all

CareLink Network Application Software 2491
Model: 2491

CareLink SmartSync Device Manager
Model: 24967, 24970A
S/N: 24967, 24970A

AIMD: App for mobile devices

AIMD: Cardiac pulse generator programmer

AIMD: Cardiac pulse generator programmer

AIMD: Implantable cardiac device management application software

AIMD: Implantable pacemaker analyser, intraoperative

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

Vk_20191003_14

22.10.2019

Boston Scientific Corporation

Advanix Pancreatic Stent
Model: M00536610, M00536620, M00536630, M00536640, M00536650, M00536660, M00536670, M00536680, M00536690, M00536700, M00536710, M00536720, M00536730
Lot: All manufactured between 18.09.2017 and 19.09.2019
S/N: N/A

MD: Polymeric pancreatic stent, non-bioabsorbable

DE-1
EN-1

Vk_20191022_01

22.10.2019

Baylis Medical Company Inc.

TorFlex Transseptal Guiding Sheath
Model: See FSN
Lot: See FSN

MD: Vascular guide-catheter, single-use

DE-1
FR-1
IT-1

Vk_20191017_07

22.10.2019

Roche Diabetes Care GmbH

Accu-Chek Solo
Lot: All lot numbers available on the market
S/N: All serial numbers available on the market
SW-Version: Not applicable

MD: Insulin infusion patch pump, electronic

DE-1-HCP
DE-1-P
FR-1-HCP
FR-1-P
EN-1-D
EN-1-HCP
EN-1-P

Vk_20191015_13

22.10.2019

Teleflex Medical

AUTO ENDO5 ML
Model: 543965/ AE05ML
Lot: SeeFSN

MD: Laparoscopic clip applier

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

Vk_20191015_02

22.10.2019

The Binding Site Group Limited

Optilite Rheumatoid Factor kit
Model: LK151.OPT
Lot: 428229

IVD: Rheumatoid factor IVD, kit, nephelometry/turbidimetry

DE-1
EN-1

Vk_20191015_01

21.10.2019

Gambro Lundia AB Monitor Division

Prismaflex
Model: 113874; 113082; 107493
SW-Version: software versions below 7.21

MD: Haemodialysis system, institutional

DE-1
FR-1
EN-1

Vk_20190910_01

18.10.2019

Medline Industries Inc.

MED-STOP Pediatric, Fingertip, Manual Vacuum Control
Model: OR854VCP

Soft suction liner 1000cc/ml with tubing and pediatric vacuum control
Model: OR54916

Soft suction liner 1500cc/ml with tubing and pediatric vacuum control
Model: OR54926

MED-STOP Pediatric (fingertip with vacuum control) + ORNEX Tubing 6mmx1.80M, Non sterile
Model: ORNEX66VCP

MD: Stopcock

MD: Suction system canister liner

MD: Suction system canister liner

MD: Stopcock

FR-1
EN-1

Vk_20191008_07

18.10.2019

Codman & Shurtleff, Inc

MedStream Refill Kit (6-pack)
Model: 91-4290
Lot: 18L092CT, 19A042CT, 19B022CT, 19B024CT

MedStream Refill Kit
Model: 91-4289
Lot: 18L091CT, 19A041CT, 19A501CT, 19A506CT, 19A507CT

Codman 3000 Series Refill Kit
Model: AP-07014
Lot: 19B212CT

AIMD: General-purpose implantable infusion pump, programmable

AIMD: General-purpose implantable infusion pump, programmable

AIMD: Implantable intrathecal infusion pump, nonprogrammable

DE-1
EN-1

Vk_20191001_10

10.10.2019 

(Updated 17.10.2019)

Randox Laboratories Ltd

Liquid Cardiac Control
Model: CQ5051, CQ5052, CQ5053
Lot: 4243CK, 4246CK, 4249CK, 4260CK, 4311CK, 4314CK, 4317CK, 4244CK, 4247CK, 4261CK, 4312CK, 4315CK, 4245CK, 4248CK, 4313CK, 4316CK

IVD: Multiple cardiac marker IVD, control

EN-1
EN-2

Vk_20191002_12

16.10.2019

Ventana Medical Systems Inc

VENTANA HE 600 System
Model: 06917259001

IVD: Microscope slide stainer IVD

EN-1

Vk_20191009_07

16.10.2019

Beckman Coulter

UniCel DxH Slidemaker Stainer (DxH SMS)
Model: 775222

UniCel DxH Slidemaker Stainer II (DxH SMS II)
Model: C11477

IVD: Specimen processing instrument IVD, automated

IVD: Haematological cell analyser IVD, automated

DE-1
FR-1
EN-1

Vk_20191007_08

27.03.2017 

(Updated 15.10.2019)

Stryker Instruments

SmartLife Large Aseptic Housing
Model: 7126-120-000
Lot: Not lot number related

MD: Rechargeable battery pack

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

Vk_20170320_02

14.10.2019

Sartorius Stedim FMT SAS

Nutripoche
Model: FNB102221, FNB103377
Lot: T0011547, T0011548

MD: Parenteral/enteral solution bag

DE-1
FR-1
IT-1

Vk_20191002_03

11.10.2019

Teleflex Medical

Arrow EZ-IO Intraosseous Vascular Access Needle Sets: 15mm Needle + Stabilizer Kit, 25mm Needle + Stabilizer Kit, 45mm Needle + Stabilizer Kit
Model: 9018P-EE-005, 9001P-EE-005, 9079P-EE-005, 9018P-EU-005, 9001P-EU-005, 9079P-EU-005, 9018P-ME-005, 9001P-ME-005, 9079P-ME-005, 9018P-NO-005, 9001P-NO-005, 9079P-NO-005, 9018P-VC-005, 9001P-VC-005, 9079P-VC-005
Lot: All

MD: Intraosseous infusion kit

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

Vk_20191004_02

11.10.2019

ConvaTec Limited

HandyVac
Model: Please refer to the FSN
Lot: Please refer to the FSN

Guedel Airway
Model: Please refer to the FSN
Lot: Please refer to the FSN

Universal Connector
Model: Please refer to the FSN
Lot: Please refer to the FSN

Exchange Bags for Unometer
Model: Please refer to the FSN
Lot: Please refer to the FSN

MD: Closed-wound drainage kit

MD: Actuator, syringe, for injector, reprocessed

MD: Open-ended non-wearable urine collection bag, sterile

MD: Nasogastric/orogastric tube

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

Vk_20191003_06

11.10.2019

Angiokard Medizintechnik GmbH

Transfusion device
Model: 5220001
Lot: 190105-000, 193723-000, 191050-000, 187600-000, 185813-000

MD: Intravenous Administration Sets

DE-1

Vk_20191002_15

08.10.2019 

(Updated 11.10.2019)

Roche Diagnostics GmbH

cobas h 232

TROPT sensitive

Cardiac Pipettes
Model: 11622889190

IVD: Multichannel clinical chemistry analyser IVD, laboratory, automated

IVD: Troponin I IVD, kit, immunochromatographic test (ICT), rapid

IVD: CH Hardware + accessories + consumables + software

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

Vk_20191001_16

08.10.2019 

(Updated 11.10.2019)

Elekta, Inc.

Monaco RTP System
SW-Version: 5.40, 5.50, 5.51

MD: Radiation therapy software

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

Vk_20191001_12

10.10.2019

Codman & Shurtleff, Inc

CereLink ICP Monitor
Model: 826820
Lot: All lots
S/N: All Serial Numbers

MD: Intracranial pressure monitor

DE-1

Vk_20191001_09

01.10.2019 

(Updated 10.10.2019)

Brainlab AG

Patient Data Manager (PDM)
Model: see FSN
SW-Version: PDM versions 2.1.1, 2.2.0, 2.2.1, 2.3.0, 2.3.1, 2.4.0, 2.5.0, 2.5.1

MD: Multidisciplinary medical image management software

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

Vk_20190930_18

09.10.2019

Siemens Healthcare Diagnostics Inc

Atellica CH 930 Analyzer
Model: 11067000
SW-Version: V1.20.0 and lower

IVD: Chemiluminescent immunoassay analyser IVD, automated

DE-1

Vk_20191007_07

09.10.2019

bioMerieux SA

VIDAS HIV P24 II
Model: 30117
Lot: 1007298100

IVD: HIV1 antigen IVD, kit, enzyme immunoassay (EIA)

EN-1

Vk_20191004_05

09.10.2019

Beckman Coulter Biomedical Limited

iChem VELOCITY Urine Chemistry Strips
Model: 800-7204
Lot: All lots

IVD: Urine rapid test device, multiple-constituent

DE-1
FR-1
EN-1

Vk_20191001_21

09.10.2019

Siemens Healthcare GmbH

SOMATOM
Model: 8098027, 10267000, 10430603, 10431700, 10590000, 10590100, 10742326
SW-Version: see FSN

MD: Full-body CT system

DE-1
FR-1

Vk_20191001_13

08.10.2019

Ortho-Clinical Diagnostics, Inc

VISION Max Analyser
Model: 6904578
Lot: N/A
S/N: N/A
SW-Version: 5.12.4 and Below

ORTHO VISION Analyser
Model: 6904579
Lot: N/A
S/N: N/A
SW-Version: 5.12.4 and Below

IVD: Immunohaematology/blood bank analyser IVD, automated

IVD: Blood group/antibody screening analyser IVD, automated

EN-1

Vk_20191007_11

08.10.2019

Philips Healthcare

Forte, Forte JETStream, Forte JETStream Upgrade, Forte JETStream AZ, Forte JETStream AZ Upgrade, Diamond Select Forte, Diamond Select Forte JETStream
Model: 882020, 882290, 882291, 882320, 882321, 889456, 889471
SW-Version: All

MD: PET/CT system

DE-1
EN-1

Vk_20191003_09

08.10.2019

Ethicon Endo-Surgery LLC

ECHELON FLEX ENDOPATH 60mm Staplers in Kit
Model: LGBP529
Lot: 10152809, 10152815

MD: Endoscopic motorized cutting stapler, single-use

DE-1
EN-1

Vk_20191003_04

08.10.2019

Baxter Healthcare SA

Thermax
Model: 955515

MD: Conduction blood/fluid warmer

DE-1

Vk_20190930_13

08.10.2019

ConvaTec Limited

Convex Two-Piece Skin Barriers i.e. Natura /Surfit
Model: see FSN
Lot: see FSN

MD: Intestinal ostomy base plate, convex

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

Vk_20190926_14

26.09.2019 

(Updated 08.10.2019)

Randox Laboratories Ltd

NEFA
Model: FA115
Lot: 485343

IVD: Non-esterified fatty acid IVD, kit, enzyme immunoassay (EIA)

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

Vk_20190923_11

07.10.2019 

(Updated 07.10.2019)

Cardia International A/S

Cardiaid, AED Electrodes
Model: CD01AE001 (CA-10ES), CD02AE001 (CR-13A)

MD: AED

DE-1
FR-1
IT-1

Vk_20190902_12

18.06.2019 

(Updated 07.10.2019)

EMED SP. Z O.O. SP. K.

RF electrosurgical unit for arthroscopy
Model: 11010042

MD: Electrosurgical Units

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

Vk_20190617_17

25.09.2019 

(Updated 04.10.2019)

Biomet Orthopedics

Various Biomet Products
Model: See FSN
Lot: See FSN

MD: (Patient Matched and Custom) Extremities, Hip, Knee, Trauma and Sample Products

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

Vk_20190925_17

03.10.2019

Terumo Europe N.V.

Terumo Hypodermic NEOLUS Needle
Model: NN-2525R // NN-2316R;NN-2525R // NN-2316R
Lot: 1906012, 1906013, 1907005, 1907006, 1907009 // 1907007, 1908002

MD: Hypodermic needle, single-use, sterile

EN-1

Vk_20190930_04

03.10.2019

Sorin Group Italia s.r.l.

VNS Therapy SenTiva Generator
Model: Model 1000
S/N: see FSN

AIMD: Antiseizure/psychiatric-therapy vagus nerve electrical stimulation system

DE-1_im Lager
DE-1_implantiert
FR-1_en stock
FR-1_implanté
EN-1_ implanted
EN-1_on stock

Vk_20190926_12

30.09.2019 

(Updated 03.10.2019)

Ortho Clinical Diagnostics Inc.

VITROS Chemistry Products Cl- & K+ Slides
Model: see FSN
Lot: see FSN

IVD: Total creatine kinase (CK) IVD, reagent

DE-1
EN-1

Vk_20190917_10

25.01.2019 

(Updated 03.10.2019)

Medtronic Inc.

Adapta, Versa, Sensia, Relia, Attesta, Sphera and Vitatron A, E, G, Q series Implantable Pulse Generators
Model: see FSN
S/N: All manufactured between Jan-2017 and Jan-2019

AIMD: Dual-chamber implantable pacemaker, rate-responsive

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

Vk_20190118_04

02.10.2019

General Medical Merate S.p.A.

Connexity
S/N: 001/101, 001/103, 001/109, 001/111, 001/112, 001/117

MD: Stationary basic diagnostic x-ray system, digital

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

Vk_20190925_16

02.10.2019

Elekta, Inc

MOSAIQ
SW-Version: Version 2.00 through 2.81

MD: Patient health record information system application software

DE-1
FR-1
EN-1

Vk_20190925_02

01.10.2019

GE Healthcare

Achilles Express, Achilles Insight
Model: see FSN
Lot: see FSN

MD: Bone absorptiometric ultrasound system

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

Vk_20190926_18

01.10.2019

Philips Ultrasound Inc.

S7-3t & S8-3t Transesophageal (TEE) Transducers
Model: see FSN

MD: General-purpose ultrasound imaging system

DE-1
FR-1
EN-1

Vk_20190926_08

01.10.2019

ImmunoIVD AB

SPOT-it TK and SPOT-it T Newborn Screening kits
Model: see FSN
Lot: see FSN

IVD: B/T lymphocyte nucleic acid kit

DE-1

Vk_20190920_14

 

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