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Batch recall of sleep safe Sets, Fresenius Medical Care PDF, 148KB, File does not meet accessibility standards Date: 15. December 2016 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - dialysis technology
Reference 10618/16

Urgent field safety notice for CentraLink Data Management System, Siemens Healthcare Diagnostics Inc. PDF, 27KB, File does not meet accessibility standards Date: 15. December 2016 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 10884/16

Urgent field safety notice for iPlan RT / iPlan RT Dose / BrainSCAN, Brainlab AG PDF, 407KB, File does not meet accessibility standards Date: 14. December 2016 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Reference 10947/16

Urgent field safety notice for Artis zee, Artis Q and Artis Q.zen, Siemens Healthcare GmbH PDF, 39KB, File does not meet accessibility standards Date: 13. December 2016 Topics: Medical devices Type: Customer information

Product group Radiological technology - radiological equipment for vascular diagnostics
Reference 10858/16

Urgent field safety notice for oneHbA1c IS, DiaSys Diagnostic Systems GmbH PDF, 149KB, File does not meet accessibility standards Date: 13. December 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 10795/16

Lot recall of Titanium Bone Screws, Anton Hipp GmbH PDF, 410KB, File does not meet accessibility standards Date: 13. December 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 10794/16

Urgent field safety notice for Heater cooler 1T / 3T / FlexTherm, Sorin Group Deutschland GmbH / LivaNova PLC PDF, 728KB, File does not meet accessibility standards Date: 09. December 2016 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 10412/16

Urgent field safety notice for cobas b 123 <3> and <4> system, Roche Diagnostics GmbH PDF, 240KB, File does not meet accessibility standards Date: 09. December 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 09909/16

Urgent field safety notice for Heater Unit HCU 40, Maquet Cardiopulmonary GmbH PDF, 498KB, File does not meet accessibility standards Date: 09. December 2016 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 10216/16

Urgent field safety notice for Heater Unit HU 35, Maquet Cardiopulmonary GmbH PDF, 88KB, File does not meet accessibility standards Date: 09. December 2016 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 10216/16

Lot recall of Alegria Anti-Instrinsic Factor / Anti-Mycoplasma pneumoniae IgM Abs., Orgentec Diagnostika GmbH PDF, 47KB, File does not meet accessibility standards Date: 08. December 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 10392/16

Recall of INRatio and INRatio 2 PT / INR Monitoring System, Alere PDF, 533KB, File does not meet accessibility standards Date: 08. December 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 05802/16

Lot recall of i-PRF Tubes 10 mL, Process for PRF / ALL YOUNG PDF, 399KB, File does not meet accessibility standards Date: 07. December 2016 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - equipment for collecting blood products and peripheral stem cells
Reference Eudamed Reference: INC-FR-16-12-000066

Urgent field safety notice for Compact Suction Unit 4 (LCSU 4), Laerdal Medical AS PDF, 603KB, File does not meet accessibility standards Date: 07. December 2016 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 10610/16

Urgent field safety notice for ORTHO VISION Max / Analyzer for ORTHO BioVue Cassettes, Ortho Clinical Diagnostics PDF, 192KB, File does not meet accessibility standards Date: 07. December 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 10194/16

Recall of NRG transseptal needle, Baylis Medical Company Inc. PDF, 181KB, File does not meet accessibility standards Date: 07. December 2016 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 08939/16

Lot recall of INGEVITY™ MRI, Boston Scientific International S. A. PDF, 240KB, File does not meet accessibility standards Date: 07. December 2016 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - cardiac pacemakers
Reference 10539/16

Lot recall of Celt ACD Femoral Artery Vascular Closure Device 5F and 6F, Vaserum Ltd. PDF, 718KB, File does not meet accessibility standards Date: 06. December 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 10389/16

Urgent Field Safey Notice for CyberKnife Systems with software version 10.6, Accuray International PDF, 78KB, File does not meet accessibility standards Date: 05. December 2016 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Reference 10473/16

Urgent field safety notice for CRT monitors Prestige 2 / Prestilix / Prestige VH / Prestige SI / RFX/SFX / Legacy / Precision 500D / ADVANTX / Innova 2000, GE Healthcare PDF, 443KB, File does not meet accessibility standards Date: 05. December 2016 Topics: Medical devices Type: Customer information

Product group Radiological technology - stationary radiological equipment
Reference 10465/16