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Urgent field safety notice for VITROS 5600 Integrated Systems, Ortho Clinical Diagnostics PDF, 833KB, File does not meet accessibility standards Date: 15. March 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 01603/16

Urgent Field Safety Notice for all HeartAssist5 Controller Driveline Cables, ReliantHeart Inc. PDF, 65KB, File does not meet accessibility standards Date: 15. March 2016 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - artificial hearts
Reference 09816/15

Urgent field safety notice for VITROS Immunodiagnostic Products Total β-hCG II Reagent Pack and Calibrators, Ortho Clinical Diagnostics GmbH PDF, 286KB, File does not meet accessibility standards Date: 10. March 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 01648/16

Urgent field safety notice for mikrozid sensitive wipes premium, Schülke & Mayr GmbH PDF, 181KB, File does not meet accessibility standards Date: 03. March 2016 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - cleaning / disinfection / sterilisation
Reference 01618/16

Urgent field safety notice for Optima XR200amx, Optima XR220amx and Brivo XR285amx X-ray imaging systems, GE Healthcare PDF, 285KB, File does not meet accessibility standards Date: 03. March 2016 Topics: Medical devices Type: Customer information

Product group Radiological technology - mobile radiological diagnostic facilities
Reference 09939/15

Urgent field safety notice for Cios Alpha mobile C-Arm system, Siemens Healthcare GmbH PDF, 263KB, File does not meet accessibility standards Date: 01. March 2016 Topics: Medical devices Type: Customer information

Product group Radiological technology - mobile radiological diagnostic facilities
Reference 01230/16

Lot recall of Hydrophilic Acrylic Single Use lntraocular Lens system packs, Rayner lntraocular Lenses Limited PDF, 362KB, File does not meet accessibility standards Date: 01. March 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 01630/16

Lot recall of BioMatrix Flex and BioMatrix NeoFlex Drug Eluting Coronary Stent System (DES), Biosensors Europe SA PDF, 325KB, File does not meet accessibility standards Date: 01. March 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 01781/16

Lot recall of SERANOX sternum wire SKU# WO80126B, Serag-Wiessner GmbH & Co. KG PDF, 130KB, File does not meet accessibility standards Date: 01. March 2016 Topics: Medical devices Type: Customer information

Product group Dressings / Pads - surgical sutures, vascular loops etc.
Reference 01779/16

Recall of SynchroMed II Implantable Infusion Pump Models 8637-20 and 8637-40, Medtronic PDF, 75KB, File does not meet accessibility standards Date: 01. March 2016 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - drug pumps
Reference 01778/16

Urgent field safety notice for Pressure Regulator, Omrix / Ethicon Inc. / Johnson & Johnson PDF, 60KB, File does not meet accessibility standards Date: 01. March 2016 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 01770/16

Lot recall of LASEREDGE 2.0 mm x 2.2 mm Trapezoid Angled 6 / Box SKU#E7601, Valeant Pharmaceuticals International Inc. PDF, 146KB, File does not meet accessibility standards Date: 01. March 2016 Topics: Medical devices Type: Customer information

Product group ophthalmological technology - equipment for ophthalmological therapeutics
Reference 01580/16

Urgent Field Safety Notice for Reveal LINQ Insertable Cardiac Monitor (ICM) Model LNQ11, Medtronic PDF, 48KB, File does not meet accessibility standards Date: 01. March 2016 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - measuring devices and sensors
Reference 01619/16

Recall for RENASYS GO External Power Supply Units, Smith & Nephew Inc. PDF, 504KB, File does not meet accessibility standards Date: 29. February 2016 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 01698/16

Lot recall for Drill Sleeve 9.0/2.8 length 191 mm for AFN, DePuy Synthes / Synthes GmbH PDF, 220KB, File does not meet accessibility standards Date: 29. February 2016 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 01701/16

Urgent Field Safety Notice for POWER LINE 4000 LEG PRESS 4xxx MED und SQUAT PRESS 4xxx MED, ERGO-FIT GmbH & Co. KG PDF, 226KB, File does not meet accessibility standards Date: 26. February 2016 Topics: Medical devices Type: Customer information

Product group Physical therapy - massage / mobility devices
Reference 01646/16

Urgent field safety notice for Nellix EndoVascular Aneurysm Sealing System, Endologix Inc. PDF, 293KB, File does not meet accessibility standards Date: 26. February 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - other implants
Reference 01127/16

Lot recall for MCS+/LDP W/FILTER 994CF-E / CONC PLT & PLS SET W/FILTER 998CF-E / PBSC SET (225 ml LATHAM) 0970E-00, Haemonetics Corporation PDF, 347KB, File does not meet accessibility standards Date: 26. February 2016 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - equipment for collecting blood products and peripheral stem cells
Reference 01658/16

Lot recall for Inflation Devices, Spiggle & Theis Medizintechnik GmbH PDF, 271KB, File does not meet accessibility standards Date: 26. February 2016 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 01570/16

Urgent field safety notice for MitraClip Clip Delivery System, Abbott Vascular PDF, 185KB, File does not meet accessibility standards Date: 25. February 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - cardiac surgery
Reference 00978/16

Urgent field safety notice AX060/15/S for Artis zee and Artis Q/Q.zen systems, Siemens Healthcare GmbH PDF, 73KB, File does not meet accessibility standards Date: 23. February 2016 Topics: Medical devices Type: Customer information

Product group Radiological technology - radiological equipment for vascular diagnostics
Reference 01254/16

Urgent field safety notice AX004/15/S for AXIOM Artis and Artis zee systems, Siemens Healthcare GmbH PDF, 74KB, File does not meet accessibility standards Date: 23. February 2016 Topics: Medical devices Type: Customer information

Product group Radiological technology - radiological equipment for vascular diagnostics
Reference 01254/16

Urgent field safety notice for RayStation 3.0 / 3.5 / 4.0 / 4.5 / 4.7, RaySearch Laboratories AB PDF, 502KB, File does not meet accessibility standards Date: 23. February 2016 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Reference 01222/16

Urgent Field Safety Notice for Extension Device 1180.19A0, MAQUET GmbH PDF, 207KB, File does not meet accessibility standards Date: 19. February 2016 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 01481/16

Batch recall for GELIPUR N, Schloss Neuhaus Güldenmoor GmbH PDF, 54KB, File does not meet accessibility standards Date: 19. February 2016 Topics: Medical devices Type: Customer information

Product group Ultrasonics - ultrasonic diagnostic equipment
Reference 08427/15

Urgent field safety notice for CytoSorb 300 ml, CytoSorbents Inc. PDF, 163KB, File does not meet accessibility standards Date: 19. February 2016 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - therapeutic apheresis procedures
Reference 00227/16

Urgent field safety notice for Acrobat 2000 spring arms, MAQUET Vertrieb und Service Deutschland GmbH PDF, 244KB, File does not meet accessibility standards Date: 19. February 2016 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 03431/09

Urgent Field Safety Notice for Bard TruGuide Disposable Coaxial Biopsy Needles, Bard Limited PDF, 37KB, File does not meet accessibility standards Date: 18. February 2016 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - gynaecology
Reference 01381/16

Corrective action for 3.7 mm D and 4.1 mm D Trabecular Metal implants, Zimmer Dental PDF, 91KB, File does not meet accessibility standards Date: 18. February 2016 Topics: Medical devices Type: Customer information

Product group Dental products - dental implants
Reference 00041/16