Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.07.2018 – 30.09.2018

Опубліковано 08.10.2018 о 11:54

Німеччина

https://www.bfarm.de/SiteGlobals/Forms/Suche/EN/kundeninfo_Filtersuche_Formular_en.html?nn=4527724

 

2018.07.05

Urgent Field Safety Notice for Volista by MAQUET SAS

Surgical equipment/ Anaesthesia – surgical equipment

PDF2MB

2018.07.04

Urgent Field Safety Notice for VISERA ELITE II VIDEO SYSTEM CENTER OLYMPUS by Olympus Medical Systems Corp.

Optics / Precision engineering – endoscopes

PDF212KB

2018.07.04

Urgent Field Safety Notice for Patientenlifter Carlo by Beka Hospitec GmbH

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

PDF146KB

2018.07.04

Urgent Field Safety Notice for Palacos und Copal Knochenzemente by Heraeus Medical GmbH

Non-active implants – materials for implants

PDF1MB

2018.07.03

Urgent Field Safety Notice for Hydraulic Ureter Dilators by Teleflex Medical

Injections / Infusions / Transfusions / Dialysis – catheters

PDF135KB

2018.07.03

Urgent Field Safety Notice for End Ball by Laboratoire ENDALIS

Non-active implants – special implants

PDF2MB

2018.07.03

Urgent Field Safety Notice for verschiedene Therapieliegen by FREI AG- Aktive Rehasysteme

Physical therapy – massage / mobility devices

PDF151KB

2018.07.02

Urgent Field Safety Notice for SQUALE by Orthopaedic & Spine Development

Non-active implants – bone surgery

PDF294KB

2018.07.13

Urgent Field Safety Notice for Radiometer ABL800 by Radiometer Medical ApS

In-vitro diagnostics – equipment / products for clinical chemistry

PDF358KB

2018.07.13

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

In-vitro diagnostics – equipment / products for clinical chemistry

PDF115KB

2018.07.12

Urgent Field Safety Notice for M1 Ambulance Co. by Stryker Medical-Kalamazoo

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

PDF151KB

2018.07.11

Urgent Field Safety Notice for EMU40 by Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)

Medical electronics / Electromedical devices – electrodiagnostics

PDF110KB

2018.07.11

Urgent Field Safety Notice for Raucodrape camera drape 16×250 in set Kitpack by Lohmann und Rauscher GmbH & Co. KG

Surgical equipment/ Anaesthesia – surgical equipment

PDF61KB

2018.07.11

Urgent Field Safety Notice for SAFIL & NOVOSYN by B. Braun Surgical S.A.

Dressings / Pads – surgical sutures, vascular loops etc.

PDF787KB

2018.07.10

Urgent Field Safety Notice for FUJIFILM Flexible Duodenoscope by FUJIFILM Corporation

Optics / Precision engineering – endoscopes

PDF74KB

2018.07.10

Urgent Field Safety Notice for OrthoScan Mini C-Arm X-Ray System by OrthoScan, Inc.

Radiological technology – mobile radiological diagnostic facilities

PDF82KB

2018.07.09

Urgent Field Safety Notice for Patient Support by Philips Medical Systems DMC GmbH

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

PDF199KB

2018.07.09

Urgent Field Safety Notice for VISIONAIRE LIGHTWEIGHT ALIGNMENT ROD by Smith & Nephew, Inc.,

Medical instruments for use in humans – bone surgery

PDF193KB

2018.07.09

Urgent Field Safety Notice for MATRIX DS by XION GmbH

Optics / Precision engineering – endoscopes

PDF281KB

2018.07.09

Urgent Field Safety Notice for Guardian Connect Application by Medtronic Minimed

Medical data processing (software) – others

PDF74KB

2018.07.06

Urgent Field Safety Notice for Leksell GammaPlan by Elekta Instrument AB

Radiotherapy / Radiation protection – radiotherapy treatment planning systems

PDF126KB

2018.07.06

Urgent Field Safety Notice for Alaris/ Asena GS,GH,CC,TIVA,PK, Syringe Pumps by CareFusion Switzerland 317 Sarl

Injections / Infusions / Transfusions / Dialysis – infusion technology

PDF238KB

2018.07.05

Urgent Field Safety Notice for ProteusPLUS by IBA (Ion Beam Applications)

Radiotherapy / Radiation protection – nuclear medical therapeutic equipment

PDF1MB

2018.07.16

Urgent Field Safety Notice for Atellica COAG 360 by Siemens Healthcare Diagnostics Products GmbH

In-vitro diagnostics – haematological, histological and cytological products

PDF664KB

2018.07.13

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

In-vitro diagnostics – equipment / products for clinical chemistry

PDF283KB

2018.07.13

Urgent Field Safety Notice for LCD Power supply (LPS) by NordicNeuroLab AS

Electromedical fields – equipment for MR tomography

PDF219KB

2018.07.13

Urgent Field Safety Notice for FilmArray Blood Culture Identification (BCID) Panel by BioFire Diagnostics, LLC

In-vitro diagnostics – microbiological products

PDF148KB

2018.07.13

Urgent Field Safety Notice for Vitamin D total II, Elecsys Vitamin D total II by Roche Diagnostics GmbH

In-vitro diagnostics – equipment / products for clinical chemistry

PDF131KB

2018.07.13

Urgent Field Safety Notice for Pereyra-Raz Ligature Carrier, Pereyra Ligature Carrier ’75, Stamey Needle by Cook Incorporated

Medical instruments for use in humans – general instruments

PDF313KB

2018.07.13

Urgent Field Safety Notice for MagNA Pure 24 System by Roche Diagnostics GmbH

In-vitro diagnostics – equipment / products for clinical chemistry

PDF115KB

2018.07.13

Urgent Field Safety Notice for QMS Teicoplanin Calibrator by Microgenics Corporation

In-vitro diagnostics – equipment / products for clinical chemistry

PDF96KB

2018.07.13

Urgent Field Safety Notice for CellSearch Circulating Tumor Cell Kit 7900001, CellSearch Epithelial Cell Kit 7900000 by Menarini Silicon Biosystems lnc.

In-vitro diagnostics – immunological products

PDF215KB

2018.07.13

Urgent Field Safety Notice for Monoclonal Mouse Anti-Human MSH2 FE11 by Dako North America, Inc.

In-vitro diagnostics – microbiological products

PDF103KB

2018.07.13

Urgent Field Safety Notice for Perifix Catheter Connector by B. Braun Melsungen AG

Injections / Infusions / Transfusions / Dialysis – infusion technology

PDF61KB

2018.07.13

Urgent Field Safety Notice for LeadcareII/Leadcare Plus by Magellan Diagnostics Inc.

In-vitro diagnostics – haematological, histological and cytological products

PDF163KB

2018.07.13

Urgent Field Safety Notice for Stamey Needle,Clarke-Reich Laparoscopic Knot Pusher,Endoscopic Introducer/Extractor,Pereyra Ligature Carrier ’75,Pereyra-Raz Ligature Carrier by Cook Incorporated / Cook Vascular

Medical instruments for use in humans – general instruments

PDF167KB

2018.07.13

Urgent Field Safety Notice for Bond Polymer Refine Detection DS9800 by Leica Biosystems Newcastle Ltd

In-vitro diagnostics – immunological products

PDF100KB

2018.07.13

Urgent Field Safety Notice for Mullkompressen 5 x 5 cm by Meditrade GmbH

Dressings / Pads – dressings

PDF1MB

2018.07.23

Urgent Field Safety Notice for Defigard Touch 7 by Schiller Medical SAS

Medical electronics / Electromedical devices – electrotherapy

PDF241KB

2018.07.23

Urgent Field Safety Notice for RayStation by RaySearch Laboratories AB

Radiotherapy / Radiation protection – radiotherapy treatment planning systems

PDF408KB

2018.07.23

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

Medical electronics / Electromedical devices – electrotherapy

PDF58KB

2018.07.20

Urgent Field Safety Notice for Arrow HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip by Arrow International Inc.

Injections / Infusions / Transfusions / Dialysis – catheters

PDF154KB

2018.07.20

Urgent Field Safety Notice for DEMOTEK Solution Administration IV set by Demophorius Healthcare LTD

Injections / Infusions / Transfusions / Dialysis – transfusion kits

PDF110KB

2018.07.19

Urgent Field Safety Notice for PLATINIUM by MicroPort CRM S.r.l.

Active implantable medical devices – defibrillators

PDF168KB

2018.07.18

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

Optics / Precision engineering – laser technology

PDF95KB

2018.07.18

Urgent Field Safety Notice for Dermatome AN by Zimmer Orthopaedic Surgical Products

Surgical equipment/ Anaesthesia – surgical equipment

PDF229KB

2018.07.17

Urgent Field Safety Notice for Jelonet 15x 2 cm Paraffingazeverband by Smith & Nephew Medical Ltd.

Dressings / Pads – dressings

PDF56KB

2018.07.17

Urgent Field Safety Notice for COPAL knee moulds by Heraeus Medical GmbH

Medical instruments for use in humans – bone surgery

PDF368KB

2018.07.17

Urgent Field Safety Notice for Trokarkatheter gerade/ trocar thorax catheter, Ch. 28 by P. J. Dahlhausen & Co.GmbH

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

PDF1MB

2018.07.16

Urgent Field Safety Notice for Persona Spacer Block Alignment Tower by Biomet Orthopaedic LLC

Medical instruments for use in humans – bone surgery

PDF75KB

2018.07.16

Urgent Field Safety Notice for Sectio Set Bielefeld incl. Safil and Novosyn by Mölnlycke Health Care AB

Dressings / Pads – surgical sutures, vascular loops etc.

PDF2MB

2018.07.16

Urgent Field Safety Notice for Chorion Villus Biopsy Needle Set by William A. Cook Australia Pty. Ltd.

Medical instruments for use in humans – general instruments

PDF437KB

2018.07.16

Urgent Field Safety Notice for OPAT RESERVOIR by Haemonetics Corporation

Injections / Infusions / Transfusions / Dialysis – transfusion kits

PDF250KB

2018.07.26

Urgent Field Safety Notice for STA Néoplastine CI 10 and CI Plus 10 by Stago

In-vitro diagnostics – haematological, histological and cytological products

PDF234KB

2018.07.26

Urgent Field Safety Notice for Radiometer ABL800 by Radiometer Medical ApS

In-vitro diagnostics – equipment / products for clinical chemistry

PDF43KB

2018.07.26

Urgent Field Safety Notice for Xpert C.Difficile BT by Cepheid AB, Solna

In-vitro diagnostics – microbiological products

PDF80KB

2018.07.26

Urgent Field Safety Notice for Xpert MTB/RIF Ultra by Cepheid AB, Solna

In-vitro diagnostics – microbiological products

PDF65KB

2018.07.26

Urgent Field Safety Notice for IMMULITE / IMMULITE 1000 Insulin, IMMULITE 2000 / 2000 XPi Insulin by Siemens Healthcare Diagnostics Inc. Tarrytown

In-vitro diagnostics – equipment / products for clinical chemistry

PDF71KB

2018.07.26

Urgent Field Safety Notice for IH-Com Kit Fullversion and IH-Com Kit For Reader by DiaMed GmbH

In-vitro diagnostics – instruments, apparatuses and systems

PDF2MB

2018.07.26

Urgent Field Safety Notice for NanoZoomer by Hamamatsu Photonics K+. K+., Systems Division Joko Factory

In-vitro diagnostics – instruments, apparatuses and systems

PDF109KB

2018.07.24

Urgent Field Safety Notice for verschiedene Therapieliegen by FREI AG- Aktive Rehasysteme

Physical therapy – massage / mobility devices

PDF185KB

2018.07.24

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

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF93KB

2018.07.24

Urgent Field Safety Notice for THERA-Trainer balo / THERA-Trainer verto by medica Medizintechnik GmbH

Physical therapy – massage / mobility devices

PDF2MB

2018.07.24

Urgent Field Safety Notice for Medumat Transport by WEINMANN Emergency Medical Technology GmbH + Co. KG

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF205KB

2018.07.24

Urgent Field Safety Notice for Hall Small Lithium Battery by ConMed Corporation

Surgical equipment/ Anaesthesia – surgical equipment

PDF135KB

2018.07.24

Urgent Field Safety Notice for 5008 CorDiax HD-PAED option by Fresenius Medical Care AG & Co. KGaA

Injections / Infusions / Transfusions / Dialysis – dialysis technology

PDF67KB

2018.07.23

Urgent Field Safety Notice for LEDVISION by Surgiris S.A.S.

Surgical equipment/ Anaesthesia – surgical equipment

PDF7MB

2018.07.23

Urgent Field Safety Notice for Applimed cannula needle straight with olive, 100mm, stainless steel, G18,diameter 1.19mm, included in Medline Sterile Procedure Trays by Medline International France SAS

2018.08.03

Urgent Field Safety Notice for ENNOVATE ROD PERSUADER by Aesculap AG

Medical instruments for use in humans – bone surgery

PDF2MB

2018.08.03

Urgent Field Safety Notice for Affixus Hip Fracture Nail by Biomet Orthopedics, LLC

Non-active implants – bone surgery

PDF260KB

2018.07.31

Urgent Field Safety Notice for VITROS Folate; FreePSA; FSH; Prolactin; TSH by Ortho Clinical Diagnostics UK

In-vitro diagnostics – immunological products

PDF1MB

2018.07.31

Urgent Field Safety Notice for ARTIS Q, ARTIS pheno by Siemens Healthcare GmbH Advanced Therapies

Radiological technology – radiological equipment for vascular diagnostics

PDF1MB

2018.07.31

Urgent Field Safety Notice for sterile Lochschrauben by aap Implantate AG

Non-active implants – bone surgery

PDF4MB

2018.07.31

Urgent Field Safety Notice for Molift 2-poing Sling Bar – all sizes by Etac Supply Gjøvik

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

PDF2MB

2018.07.30

Urgent Field Safety Notice for ARCHITECT Creatine Kinase by Abbott Laboratories

In-vitro diagnostics – equipment / products for clinical chemistry

PDF115KB

2018.07.30

Urgent Field Safety Notice for Human IgM Kit for SPA PLUS – NK012.S by The Binding Site Group Limited

In-vitro diagnostics – microbiological products

PDF4MB

2018.07.30

Urgent Field Safety Notice for Alinity s System by Abbott GmbH & Co. KG

In-vitro diagnostics – equipment / products for clinical chemistry

PDF121KB

2018.07.30

Urgent Field Safety Notice for Alinity c Creatinine Reagent Kit by Abbott GmbH & Co. KG

In-vitro diagnostics – equipment / products for clinical chemistry

PDF114KB

2018.07.30

Urgent Field Safety Notice for recomWell Borrelia IgM by Mikrogen GmbH

In-vitro diagnostics – microbiological products

PDF1MB

2018.07.27

Urgent Field Safety Notice for Carescape R860 by GE Healthcare Technologies (Datex Ohmeda)

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF564KB

2018.07.26

Urgent Field Safety Notice for VIDAS CA 15-3 by bioMérieux S. (Marcy- l’Etoile)

In-vitro diagnostics – immunological products

PDF123KB

2018.07.26

Urgent Field Safety Notice for EZ1 Advanced XL by QIAGEN GmbH

In-vitro diagnostics – equipment / products for clinical chemistry

PDF391KB

2018.07.26

Urgent Field Safety Notice for ARCHITECT c4000 / c8000 / c16000 Processing Module by Abbott Laboratories (Abbott Park)

In-vitro diagnostics – equipment / products for clinical chemistry

PDF162KB

2018.08.09

Urgent Field Safety Notice for AXIOM MULTIX, MT, ACSS,P,N, AXIOM MULTIX, MT, ACSS,N, AXIOM MULTIX, MT, AXIOM Vertix Solitaire M-System_T, AXIOM ARISTOS VX Plus by Siemens Healthcare GmbH, X-Ray Products (XP)

Radiological technology – stationary radiological equipment

PDF3MB

2018.08.09

Urgent Field Safety Notice for Stellaris Elite Single Port Vitrectomy Cutters by Bausch & Lomb Inc

ophthalmological technology – equipment for ophthalmological therapeutics

PDF172KB

2018.08.09

Urgent Field Safety Notice for Rusch Green Lite (MAC 3) by Teleflex Medical Athlone

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

PDF208KB

2018.08.09

Urgent Field Safety Notice for M300 by Draeger Medical Systems, Inc

Medical electronics / Electromedical devices – electrodiagnostics

PDF1MB

2018.08.08

Urgent Field Safety Notice for Knob Assembly contained in MAYFIELD by Integra LifeSciences Corp

Surgical equipment/ Anaesthesia – surgical equipment

PDF809KB

2018.08.08

Urgent Field Safety Notice for TRENDHIP STANDARD CEM.LESS 12/14 SIZE 2 by Groupe Lepine

Non-active implants – bone surgery

PDF25KB

2018.08.08

Urgent Field Safety Notice for Zytologiebürste Einweg by FENDO Medizinztechnik e.K.

Medical instruments for use in humans – cardiac/thorax surgery

PDF46KB

2018.08.07

Urgent Field Safety Notice for GC85A, GM85, GC80, GC70, GU60A, GF50, and GR40CW by Samsung Electronics Co. Limited

Radiological technology – stationary radiological equipment

PDF90KB

2018.08.07

Urgent Field Safety Notice for Alcon LuxOR E71 Ophthalmic Microscope; Alcon LuxOR E71 Q-Vue Ophthalmic by Alcon Laboratories, Inc.

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

PDF170KB

2018.08.07

Urgent Field Safety Notice for Sonolith i-move by EDAP TMS France S.A.

Ultrasonics – ultrasonic therapeutic equipment

PDF1MB

2018.08.07

Urgent Field Safety Notice for MAKO Vizadisc Knee/Hip Procedure Tracking Kit by MAKO Surgical Corp.

Surgical equipment/ Anaesthesia – surgical equipment

PDF151KB

2018.08.06

Urgent Field Safety Notice for Dr. Mach Operationsleuchte mit Schwerer Zentralachse by Dr. Mach GmbH & Co. KG

Surgical equipment/ Anaesthesia – surgical equipment

PDF135KB

2018.08.06

Urgent Field Safety Notice for MyLab Diverse by Esaote S.p.A.

Ultrasonics – ultrasonic diagnostic equipment

PDF94KB

2018.08.06

Urgent Field Safety Notice for Ureterorenoskop; Ureterorenoskop; Nephroskop by Schölly Fiberoptic GmbH

Optics / Precision engineering – endoscopes

PDF2MB

2018.08.06

Urgent Field Safety Notice for LipiVage Harvester w/Cannula by Genesis Biosystems

Surgical equipment/ Anaesthesia – surgical equipment

PDF9KB

2018.08.20

Urgent Field Safety Notice for Miele Sterilisatoren by Miele & Cie. KG

General equipment for medical treatment – cleaning / disinfection / sterilisation

PDF2MB

2018.08.20

Urgent Field Safety Notice for Organ Care System (OCS) Heart by TransMedics, Inc.

Surgical equipment/ Anaesthesia – surgical equipment

PDF228KB

2018.08.20

Urgent Field Safety Notice for 611P CT Lucia by Carl-Zeiss-Meditec AG

Non-active implants – special implants

PDF245KB

2018.08.20

Urgent Field Safety Notice for sterEOS workstation by EOS imaging

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

PDF307KB

2018.08.20

Urgent Field Safety Notice for Durex “Real Feel” Polyisoprene Condoms by Reckitt Benckiser Healthcare International

Contraception – condoms

PDF87KB

2018.08.20

Urgent Field Safety Notice for Miele Sterilisatoren by Miele & Cie. KG

General equipment for medical treatment – cleaning / disinfection / sterilisation

PDF3MB

2018.08.20

Urgent Field Safety Notice for Hemodialysis Products by Medcomp Medical Components, Inc.

Injections / Infusions / Transfusions / Dialysis – catheters

PDF311KB

2018.08.20

Urgent Field Safety Notice for BIS Vista and BIS View Monitoring Systems by Covidien llc

Medical electronics / Electromedical devices – electrodiagnostics

PDF998KB

2018.08.20

Urgent Field Safety Notice for RYTHMIC EVOLUTION by MICREL MEDICAL DEVICES SA

Injections / Infusions / Transfusions / Dialysis – infusion technology

PDF312KB

2018.08.20

Urgent Field Safety Notice for MobileDiagnost wDR by Philips Medical Systems DMC GmbH

Radiological technology – stationary radiological equipment

PDF56KB

2018.08.20

Urgent Field Safety Notice for MetaVision Suite, Clinical Information System& EHR by iMDsoft Ltd.

Medical data processing (software) – others

PDF294KB

2018.08.10

Urgent Field Safety Notice for Philips SureSigns VS & VM Monitors, and View Stati by Philips Medical Systems

Medical electronics / Electromedical devices – electrodiagnostics

PDF280KB

2018.08.10

Urgent Field Safety Notice for Heater-Cooler Unit HCU 40 by Maquet Cardiopulmonary AG

Surgical equipment/ Anaesthesia – surgical equipment

PDF30KB

2018.08.09

Urgent Field Safety Notice for Ysio, Ysio Max, Ysio Fully, Ysio Semi by Siemens Healthcare GmbH, X-Ray Products (XP)

Radiological technology – stationary radiological equipment

PDF3MB

2018.08.09

Urgent Field Safety Notice for AEROtube-ET01-65M-SET, Endotrachealtubus-SET,mit Manschette, einzeln steril verpackt, 6,5 mm,CH 26 by HUM Gesellschaft für Homecare und Medizintechnik mbH

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF7MB

2018.08.21

Urgent Field Safety Notice for ARCHITECT EBV VCA IgM Controls by Abbott GmbH & Co.KG

In-vitro diagnostics – microbiological products

PDF100KB

2018.08.21

Urgent Field Safety Notice for Minicon Clinical Sample Concentrators by Merck Millipore Ltd

In-vitro diagnostics – equipment / products for clinical chemistry

PDF60KB

2018.08.21

Urgent Field Safety Notice for cobas m 511 integrated hematology analyzer by Roche Diagnostics GmbH

In-vitro diagnostics – haematological, histological and cytological products

PDF739KB

2018.08.21

Urgent Field Safety Notice for Hematek Modified Wright / Wright-Giemsa Stain Pack by Siemens Healthcare Diagnostics Inc. Tarrytown

In-vitro diagnostics – haematological, histological and cytological products

PDF65KB

2018.08.21

Urgent Field Safety Notice for Oxoid CT0159B by Remel Europe. Part of Thermo Fisher Scientific

In-vitro diagnostics – microbiological products

PDF86KB

2018.08.21

Urgent Field Safety Notice for 611P CT Lucia by Carl-Zeiss-Meditec AG

Non-active implants – special implants

PDF217KB

2018.08.21

Urgent Field Safety Notice for power supply for div. sleep therapy devices by Löwenstein Medical Technology GmbH + Co. KG

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF115KB

2018.08.21

Urgent Field Safety Notice for RAPIDPoint 405 500 and RAPIDLab 1245 1265 by Siemens Healthcare Diagnostics Inc. Tarrytown

In-vitro diagnostics – equipment / products for clinical chemistry

PDF66KB

2018.08.20

Urgent Field Safety Notice for AIRO Mobile CT System by Mobius Imaging, LLC

Radiological technology – CT scanners

PDF340KB

2018.08.20

Urgent Field Safety Notice for ZNN TIBIAL NAIL by Zimmer Biomet, Inc. Warsaw

Non-active implants – bone surgery

PDF307KB

2018.08.20

Urgent Field Safety Notice for MiniMed remote controller by Medtronic Minimed

Injections / Infusions / Transfusions / Dialysis – infusion technology

PDF134KB

2018.08.20

Urgent Field Safety Notice for Allura Xper and Integris Allura Systems by Philips Medical Systems Nederland B.V.

Radiological technology – radiological equipment for vascular diagnostics

PDF229KB

2018.08.20

Urgent Field Safety Notice for Direct Radiography system DX-D 600 by Agfa HealthCare N.V.

Radiological technology – stationary radiological equipment

PDF187KB

2018.08.20

Urgent Field Safety Notice for ECO Bath by CareNow Medical Pvt. Ltd.

Surgical equipment/ Anaesthesia – surgical equipment

PDF256KB

2018.08.20

Urgent Field Safety Notice for Endocavity Needle Guide by CIVCO Medical Instruments Co., Inc. d.b.a CIVCO Medical Solutions

Medical instruments for use in humans – cardiac/thorax surgery

PDF71KB

2018.08.23

Urgent Field Safety Notice for BE-HLS 7050#HLS Set Advanced 7.0 by Maquet Cardiopulmonary AG

Surgical equipment/ Anaesthesia – surgical equipment

PDF30KB

2018.08.23

Urgent Field Safety Notice for AMSCO V-PRO 1, V-PRO 1 Plus, VPRO maX by Steris Corporation

General equipment for medical treatment – cleaning / disinfection / sterilisation

PDF154KB

2018.08.22

Urgent Field Safety Notice for Cannulated Screw-sterile Lochschrauben by aap Implantate AG

Non-active implants – bone surgery

PDF731KB

2018.08.22

Urgent Field Safety Notice for Varilymph 12 Pro by SLK Vertriebsgesellschaft mbH

Physical therapy – massage / mobility devices

PDF307KB

2018.08.22

Urgent Field Safety Notice for Cardioband by Edwards Cardioband

Non-active implants – cardiac surgery

PDF877KB

2018.08.22

Urgent Field Safety Notice for Hiploc Plate by Biomet UK Ltd

Non-active implants – bone surgery

PDF135KB

2018.08.22

Urgent Field Safety Notice for DORO LUCENT Base Unit by PMI pro med Instruments GmbH

Surgical equipment/ Anaesthesia – surgical equipment

PDF12MB

2018.08.22

Urgent Field Safety Notice for ADVIA Centuar CKMB Calibrator/Atellica CKMB Calibrator by Siemens Healthcare Diagnostics Inc. Tarrytown

In-vitro diagnostics – equipment / products for clinical chemistry

PDF423KB

2018.08.22

Urgent Field Safety Notice for Ergo Just Cart by Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)

Medical electronics / Electromedical devices – ENT equipment

PDF179KB

2018.08.21

Urgent Field Safety Notice for AST-P640 Test Kit and AST-P655 Test Kit by bioMérieux Inc

In-vitro diagnostics – microbiological products

PDF383KB

2018.08.21

Urgent Field Safety Notice for Transplant-Aspiration Needle, SPI-CUT by Somatex Medical Technologies GmbH / Berlin

Medical instruments for use in humans – general instruments

PDF361KB

2018.08.21

Urgent Field Safety Notice for Rotating IV pole by GE Healthcare Clinical Systems (Ohmeda Medical)

Injections / Infusions / Transfusions / Dialysis – infusion technology

PDF381KB

2018.08.21

Urgent Field Safety Notice for Drill CS 2.7/3.5, ø2.7, L 130, quick coupling by aap Implantate AG

Medical instruments for use in humans – bone surgery

PDF710KB

2018.08.21

Urgent Field Safety Notice for Output Unit by Hitachi, Ltd.

In-vitro diagnostics – equipment / products for clinical chemistry

PDF101KB

2018.08.21

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

In-vitro diagnostics – haematological, histological and cytological products

PDF57KB

2018.08.31

Urgent Field Safety Notice for Mayfield tracker by Scopis GmbH

Surgical equipment/ Anaesthesia – surgical equipment

PDF141KB

2018.08.30

Urgent Field Safety Notice for Sterile single use electrosurgical pencil by Wickimed (Huizhou) Medical Equipment Manufacturing Co Ltd

Medical electronics / Electromedical devices – electrotherapy

PDF93KB

2018.08.30

Urgent Field Safety Notice for Mon-a-ThermT Foley catheters with temperature sens by Degania Silicone Ltd.

Injections / Infusions / Transfusions / Dialysis – catheters

PDF1MB

2018.08.29

Urgent Field Safety Notice for Taenia solium IgG ELISA by IBL International GmbH

In-vitro diagnostics – microbiological products

PDF167KB

2018.08.29

Urgent Field Safety Notice for T.E.S.S Glenoid Drill 5mm by Biomet France SARL

Medical instruments for use in humans – bone surgery

PDF335KB

2018.08.29

Urgent Field Safety Notice for Grip Strapper by Liko AB

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

PDF296KB

2018.08.29

Urgent Field Safety Notice for IgG4 Food screen 280 ELISA by IBL International GmbH

In-vitro diagnostics – immunological products

PDF508KB

2018.08.29

Urgent Field Safety Notice for NeoBase Succinylacetone Assay Solution by PerkinElmer Life and Analytical Sciences, Wallac Oy

In-vitro diagnostics – equipment / products for clinical chemistry

PDF31KB

2018.08.29

Urgent Field Safety Notice for Zenith Alpha Thoracic Endovascular Graft by William Cook Europe ApS

Non-active implants – special implants

PDF72KB

2018.08.29

Urgent Field Safety Notice for VITROS 5600 Integrated System by Ortho-Clinical Diagnostics, Inc.

In-vitro diagnostics – equipment / products for clinical chemistry

PDF1MB

2018.08.24

Urgent Field Safety Notice for Vitality Shear-off Set Screw by Zimmer Biomet Spine, Inc

Non-active implants – bone surgery

PDF397KB

2018.08.24

Urgent Field Safety Notice for Geratherm Patient Warming System UniqueTemp° Recovery, Recovery Set 1 by Geratherm Medical AG

Surgical equipment/ Anaesthesia – surgical equipment

PDF2MB

2018.08.24

Urgent Field Safety Notice for TrueBeam & EDGE Radiotherapy Delivery Systems by Varian Medical Systems, Inc.

Radiotherapy / Radiation protection – radiation facilites with accelerators for teletherapy

PDF241KB

2018.08.23

Urgent Field Safety Notice for Multix Fusion by Siemens Shanghai Medical Equipment Ltd. (SSME)

Radiological technology – stationary radiological equipment

PDF2MB

2018.08.23

Urgent Field Safety Notice for Affixus Hip Fracture Nail by Biomet Orthopedics, LLC

Non-active implants – bone surgery

PDF371KB

2018.08.31

Urgent Field Safety Notice for Mayfield tracker by Scopis GmbH

Surgical equipment/ Anaesthesia – surgical equipment

PDF141KB

2018.08.30

Urgent Field Safety Notice for Sterile single use electrosurgical pencil by Wickimed (Huizhou) Medical Equipment Manufacturing Co Ltd

Medical electronics / Electromedical devices – electrotherapy

PDF93KB

2018.08.30

Urgent Field Safety Notice for Mon-a-ThermT Foley catheters with temperature sens by Degania Silicone Ltd.

Injections / Infusions / Transfusions / Dialysis – catheters

PDF1MB

2018.08.29

Urgent Field Safety Notice for Taenia solium IgG ELISA by IBL International GmbH

In-vitro diagnostics – microbiological products

PDF167KB

2018.08.29

Urgent Field Safety Notice for T.E.S.S Glenoid Drill 5mm by Biomet France SARL

Medical instruments for use in humans – bone surgery

PDF335KB

2018.08.29

Urgent Field Safety Notice for Grip Strapper by Liko AB

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

PDF296KB

2018.08.29

Urgent Field Safety Notice for IgG4 Food screen 280 ELISA by IBL International GmbH

In-vitro diagnostics – immunological products

PDF508KB

2018.08.29

Urgent Field Safety Notice for NeoBase Succinylacetone Assay Solution by PerkinElmer Life and Analytical Sciences, Wallac Oy

In-vitro diagnostics – equipment / products for clinical chemistry

PDF31KB

2018.08.29

Urgent Field Safety Notice for Zenith Alpha Thoracic Endovascular Graft by William Cook Europe ApS

Non-active implants – special implants

PDF72KB

2018.08.29

Urgent Field Safety Notice for VITROS 5600 Integrated System by Ortho-Clinical Diagnostics, Inc.

In-vitro diagnostics – equipment / products for clinical chemistry

PDF1MB

2018.08.24

Urgent Field Safety Notice for Vitality Shear-off Set Screw by Zimmer Biomet Spine, Inc

Non-active implants – bone surgery

PDF397KB

2018.08.24

Urgent Field Safety Notice for Geratherm Patient Warming System UniqueTemp° Recovery, Recovery Set 1 by Geratherm Medical AG

Surgical equipment/ Anaesthesia – surgical equipment

PDF2MB

2018.08.24

Urgent Field Safety Notice for TrueBeam & EDGE Radiotherapy Delivery Systems by Varian Medical Systems, Inc.

Radiotherapy / Radiation protection – radiation facilites with accelerators for teletherapy

PDF241KB

2018.08.23

Urgent Field Safety Notice for Multix Fusion by Siemens Shanghai Medical Equipment Ltd. (SSME)

Radiological technology – stationary radiological equipment

PDF2MB

2018.08.23

Urgent Field Safety Notice for Affixus Hip Fracture Nail by Biomet Orthopedics, LLC

Non-active implants – bone surgery

PDF371KB

2018.09.10

Urgent Field Safety Notice for EEA Circular Stapler with Tri-Staple Technology by Covidien llc

Medical instruments for use in humans – general instruments

PDF203KB

2018.09.10

Urgent Field Safety Notice for Aptio Automation / StremaLAB Automation by Siemens Healthcare Diagnostics Inc. Tarrytown

In-vitro diagnostics – equipment / products for clinical chemistry

PDF88KB

2018.09.10

Urgent Field Safety Notice for Unity Drill Assembly Unit, .021 Green by Coltene/Whaledent, lnc.

Dental products – instruments

PDF778KB

2018.09.06

Urgent Field Safety Notice for Various brand of IV catheter by Mediplus (India) Linited

Injections / Infusions / Transfusions / Dialysis – catheters

PDF16MB

2018.09.06

Urgent Field Safety Notice for Y-Ventil by Sunny Medical Device (Shenzhen) Co., Ltd.

Injections / Infusions / Transfusions / Dialysis – infusion technology

PDF95KB

2018.09.05

Urgent Field Safety Notice for s.pump by Medos Medizintechnik AG

Surgical equipment/ Anaesthesia – surgical equipment

PDF385KB

2018.09.05

Urgent Field Safety Notice for Xper Flex Cardio Physiomonitoring System by Philips Medical Systems

Medical electronics / Electromedical devices – electrodiagnostics

PDF32KB

2018.09.04

Urgent Field Safety Notice for CyberKnife Robotic Radiosurgery System by Accuray Incorporated

Radiotherapy / Radiation protection – radiotherapy treatment planning systems

PDF151KB

2018.09.04

Urgent Field Safety Notice for Intrafix SafeSet Standard, 180 cm by B. Braun Melsungen AG

Injections / Infusions / Transfusions / Dialysis – infusion kits

PDF85KB

2018.09.04

Urgent Field Safety Notice for AlarisT/ AsenaT CC, GH Syringe Pump by BD Switzerland Sarl

Injections / Infusions / Transfusions / Dialysis – infusion technology

PDF306KB

2018.09.04

Urgent Field Safety Notice for AlignRT by VisionRT Ltd

Radiotherapy / Radiation protection – radiotherapy treatment planning systems

PDF774KB

2018.09.04

Urgent Field Safety Notice for General Impactor by Stanmore Implants Worldwide Ltd

Medical instruments for use in humans – bone surgery

PDF489KB

2018.09.04

Urgent Field Safety Notice for AWC-Additional Working Channel by Ovesco Endoscopy AG

Optics / Precision engineering – endoscopes

PDF386KB

2018.09.03

Urgent Field Safety Notice for Leica M525 by Leica Microsystems (Schweiz) AG

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

PDF2MB

2018.08.31

Urgent Field Safety Notice for EO-150 Ventilator by EOVE

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF110KB

2018.09.13

Urgent Field Safety Notice for ACCOLADE, ACCOLADE MRI; PROPONENT, PPOPONENT MRI; ESSENTIO, ESSENTIO MRI; VISIONIST X4; VALITUDE X4 by Boston Scientific CRM

Active implantable medical devices – cardiac pacemakers

PDF38KB

2018.09.13

Urgent Field Safety Notice for Neuro Omega by Alpha Omega Engineering Ltd.

Surgical equipment/ Anaesthesia – surgical equipment

PDF251KB

2018.09.12

Urgent Field Safety Notice for Cell Observer S., DirectFRAP, Laser TIRF by Carl Zeiss Microscopy GmbH

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

PDF127KB

2018.09.11

Urgent Field Safety Notice for Getinge WD15 Claro by Getinge Disinfection AB

General equipment for medical treatment – cleaning / disinfection / sterilisation

PDF478KB

2018.09.11

Urgent Field Safety Notice for RePlant Precision IO Scan Adapter by Implant Direct Sybron Manufacturing, LLC.

Dental products – dental implants

PDF205KB

2018.09.10

Urgent Field Safety Notice for Cannulated tap, 5.5 mm by icotec ag

Medical instruments for use in humans – bone surgery

PDF2MB

2018.09.10

Urgent Field Safety Notice for Enzymatic Creatinine OSR6x204, HDL Cholesterol OSR6x87, Lipase OSR6x30 and Uric Acid OSR6x98 by Beckman Coulter Ireland Inc.

In-vitro diagnostics – equipment / products for clinical chemistry

PDF698KB

2018.09.10

Urgent Field Safety Notice for FLEX Monoclonal Mouse Anti-Human Progesterone Rece by Dako North America, Inc.

In-vitro diagnostics – immunological products

PDF46KB

2018.09.10

Urgent Field Safety Notice for ClinRep UHPLC Komplettkit Antiepileptika by RECIPE Chemicals + Instruments GmbH

In-vitro diagnostics – equipment / products for clinical chemistry

PDF874KB

2018.09.10

Urgent Field Safety Notice for Accu-Chek Inform II, cobas h 232 POC, CoaguChek Pro II, CoaguChek XS Plus/XS Pro by Roche Diagnostics GmbH

In-vitro diagnostics – others

PDF482KB

2018.09.10

Urgent Field Safety Notice for Alinity hq Analyzer by Abbott GmbH & Co. KG

In-vitro diagnostics – haematological, histological and cytological products

PDF117KB

2018.09.10

Urgent Field Safety Notice for NOVA FA (POL YRAD PREMIUM CSAP) by SEDECAL S. A.

Radiological technology – stationary radiological equipment

PDF109KB

2018.09.10

Urgent Field Safety Notice for Suction Catheters, Gastro-enteral Tubes by ConvaTec Limited Deeside

Surgical equipment/ Anaesthesia – surgical equipment

PDF441KB

2018.09.10

Urgent Field Safety Notice for Alinity s System by Abbott GmbH & Co. KG

In-vitro diagnostics – equipment / products for clinical chemistry

PDF102KB

2018.09.10

Urgent Field Safety Notice for cobas e411 by Hitachi High-Technologies, Medical Systems QA Group

In-vitro diagnostics – equipment / products for clinical chemistry

PDF532KB

2018.09.21

Urgent Field Safety Notice for O-ARM Imaging System by Medtronic Navigation Inc.

Radiological technology – navigation systems

PDF53KB

2018.09.20

Urgent Field Safety Notice for Low Volume IV Filter / BC 693 by Bayer Medical Care Inc.

Injections / Infusions / Transfusions / Dialysis – infusion kits

PDF49KB

2018.09.20

Urgent Field Safety Notice for Peek Acuity Pro by Peek Vision Ltd

Medical data processing (software) – facet_09md-07

PDF107KB

2018.09.20

Urgent Field Safety Notice for AFX EndoVascular AAA System by Endologix, Inc.

Non-active implants – special implants

PDF367KB

2018.09.20

Urgent Field Safety Notice for Diverse Dentalimplantate by VICTORY

Dental products – dental implants

PDF545KB

2018.09.18

Urgent Field Safety Notice for Lone Star Single-Use Elastic Stays by Cooper Surgical Inc.

Medical instruments for use in humans – visceral surgery

PDF199KB

2018.09.17

Urgent Field Safety Notice for FilmArray Blood Culture Identification (BCID) Panel by BioFire Diagnostics, LLC

In-vitro diagnostics – microbiological products

PDF171KB

2018.09.17

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

In-vitro diagnostics – equipment / products for clinical chemistry

PDF43KB

2018.09.17

Urgent Field Safety Notice for Accelerator a3600 by Inpeco SA

In-vitro diagnostics – equipment / products for clinical chemistry

PDF2MB

2018.09.17

Urgent Field Safety Notice for Aptio Automation by Inpeco SA

In-vitro diagnostics – equipment / products for clinical chemistry

PDF1MB

2018.09.17

Urgent Field Safety Notice for ALTRIX, 220-240V/50HZ, TYPE F by Stryker Medical-Kalamazoo

Surgical equipment/ Anaesthesia – surgical equipment

PDF626KB

2018.09.17

Urgent Field Safety Notice for Alere Triage NT-proBNP Test by Alere San Diego, Inc.

In-vitro diagnostics – immunological products

PDF111KB

2018.09.17

Urgent Field Safety Notice for CARESCAPE Monitor B650 by GE Healthcare Finland Oy

Medical electronics / Electromedical devices – electrodiagnostics

PDF540KB

2018.09.13

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

Injections / Infusions / Transfusions / Dialysis – catheters

PDF920KB

2018.09.13

Urgent Field Safety Notice for LATITUDE Programmer by Boston Scientific CRM

Active implantable medical devices – cardiac pacemakers

PDF225KB

2018.09.25

Urgent Field Safety Notice for FlexLab by Inpeco SA

In-vitro diagnostics – instruments, apparatuses and systems

PDF46KB

2018.09.25

Urgent Field Safety Notice for Single-Use, Colpo-Pneumo Occluder by Cooper Surgical Inc.

Medical instruments for use in humans – gynaecology

PDF232KB

2018.09.25

Urgent Field Safety Notice for SIRSCAN® DISCS Amoxicilline 2µg +Acide clavulanique 1µg by I2A – Intelligence Artificielle Applications

In-vitro diagnostics – microbiological products

PDF319KB

2018.09.25

Urgent Field Safety Notice for Alinity i Processing Module by Abbott GmbH & Co. KG

In-vitro diagnostics – equipment / products for clinical chemistry

PDF90KB

2018.09.25

Urgent Field Safety Notice for Calibrateur HDL LDL CK-MB ref 95506 & Sérum de contrôle HDL LDLCK-MB Lipides (ref 95516 & 95526) by BIOLABO

In-vitro diagnostics – equipment / products for clinical chemistry

PDF201KB

2018.09.25

Urgent Field Safety Notice for ekamove 30°Seitenlagerungssystem (HIMI:11.29.1003) by ekamed GmbH & Co. KG

General equipment for medical treatment – furnishings

PDF1MB

2018.09.25

Urgent Field Safety Notice for Pastorex Meningitis by Bio-Rad Laboratories France

In-vitro diagnostics – microbiological products

PDF426KB

2018.09.25

Urgent Field Safety Notice for Kaluza C Software version 1.0 by Beckman Coulter, Inc.

In-vitro diagnostics – haematological, histological and cytological products

PDF189KB

2018.09.25

Urgent Field Safety Notice for PATHFAST by LSI Medience Corporation

In-vitro diagnostics – equipment / products for clinical chemistry

PDF521KB

2018.09.25

Urgent Field Safety Notice for GENESIS II NON POROUS C/R FEMORAL SIZE 6 RIGHT by Smith & Nephew Orthopaedics GmbH

Non-active implants – bone surgery

PDF115KB

2018.09.25

Urgent Field Safety Notice for Dimension Lipase / Dimension Vista Lipase by Siemens Healthcare Diagnostics Inc. Newark

In-vitro diagnostics – equipment / products for clinical chemistry

PDF73KB

2018.09.24

Urgent Field Safety Notice for BD Micro-Fine Ultra by Becton Dickinson Franklin Lakes

Injections / Infusions / Transfusions / Dialysis – insulin pens and pen cannulas

PDF115KB

2018.09.21

Urgent Field Safety Notice for KURZ-Precise Schneideblock by Heinz Kurz GmbH Medizintechnik

Medical instruments for use in humans – bone surgery

PDF170KB

2018.09.21

Urgent Field Safety Notice for HeartWare Ventricular Assist System by Heartware, Inc.

Active implantable medical devices – artificial hearts

PDF279KB

2018.09.21

Urgent Field Safety Notice for CentriMag Blood Pumping System by Thoratec Corporation

Surgical equipment/ Anaesthesia – surgical equipment

PDF642KB

2018.09.26

Urgent Field Safety Notice for CrystalClear Plus, RUSCH CARE CrystalClear (PVC) Tracheostomy Cannula (no Cuff) – Set, RUSCH CrystalClear (PVC) Tracheostomy Cannula (Cuffed), RUSCH CrystalClear (PVC) Tracheostomy by Teleflex (Perak West Malaysia)

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF211KB

2018.09.26

Urgent Field Safety Notice for 220-240V Unit Cable (power cord) by B. Braun Melsungen AG

Injections / Infusions / Transfusions / Dialysis – infusion technology

 

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