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Urgent Field Safety Notice for TnI-Ultra - Biotin Interference, Siemens Healthcare Diagnostics Inc. PDF, 64KB, File does not meet accessibility standards Date: 17. May 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 04036/16

Urgent field safety notice for Eva Mobile Lifts, Handicare AB PDF, 595KB, File does not meet accessibility standards Date: 13. May 2016 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - ward equipment and equipment for emergency medical services
Reference 03777/16

Recall of Clinpro Glycine Prophy Powder with TCP, 3M Deutschland GmbH PDF, 103KB, File does not meet accessibility standards Date: 13. May 2016 Topics: Medical devices Type: Customer information

Product group Dental products - instruments
Reference 04034/16

Lot recall of Hygro-c Inserter, privelop-spine AG PDF, 99KB, File does not meet accessibility standards Date: 12. May 2016 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 03472/16

Urgent field safety notice for ADVIA Centaur XPT System (SMN 10711433), Siemens Healthcare Diagnostics Inc. PDF, 25KB, File does not meet accessibility standards Date: 12. May 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 03991/16

Lot recall of TRUEresult Blood Glucose Test Strips (GDH-FAD), Nipro Diagnostics / Nipro Europe PDF, 238KB, File does not meet accessibility standards Date: 12. May 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 03864/16

Urgent Field Safety Notice for AssayTip / AssayCup, Roche PDF, 164KB, File does not meet accessibility standards Date: 12. May 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 03683/16

Urgent field safety notice for rechargeable implantable neurostimulators RestoreSensor / RestoreSensor SureScan MRI (models 37714 and 97714), Medtronic PDF, 84KB, File does not meet accessibility standards Date: 12. May 2016 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - biostimulators
Reference 03832/16

Urgent field safety notice for Sternal Retractor, Genesee BioMedical Inc. / Landmark Surgical PDF, 178KB, File does not meet accessibility standards Date: 12. May 2016 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - general instruments
Reference 02665/16

Urgent field safety notice for Commander Delivery System (Models 9610TF23 / 9610TF26 / 9610TF29), Edwards Lifesciences PDF, 67KB, File does not meet accessibility standards Date: 12. May 2016 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 03982/16

Lot recall for GEM Microvascular Anastomotic Coupler, Synovis Micro Companies Alliance Inc. / Baxter International Inc. PDF, 388KB, File does not meet accessibility standards Date: 12. May 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 03688/16

Urgent field safety notice for ProcedurePak kits and trays with umbilical clamps IFKR21, Mölnlycke Health Care PDF, 87KB, File does not meet accessibility standards Date: 11. May 2016 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - gynaecology
Reference 01850/16

Urgent field safety notice for ProcedurePak with umbilical clamps IFKR08, Mölnlycke Health Care PDF, 136KB, File does not meet accessibility standards Date: 11. May 2016 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - gynaecology
Reference 01011/16

Urgent Field Safety Notice for MobileDiagnost wDR 2, Philips Medical Systems PDF, 27KB, File does not meet accessibility standards Date: 11. May 2016 Topics: Medical devices Type: Customer information

Product group Radiological technology - stationary radiological equipment
Reference 03751/16

Lot recall of CELL-DYN Emerald Cleaner, Abbott Laboratories PDF, 68KB, File does not meet accessibility standards Date: 11. May 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 03869/16

Urgent Field Safety Notice for cobas b 123 Sensor Cartridge BG/ISE, Roche Diagnostics GmbH PDF, 432KB, File does not meet accessibility standards Date: 11. May 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 03825/16

Lot recall of Surefuser, NIPRO MEDICAL EUROPE PDF, 98KB, File does not meet accessibility standards Date: 10. May 2016 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 03504/16

Lot recall of Ebb Complete Tamponade System (CTS-1000), Clinical Innovations LLC PDF, 187KB, File does not meet accessibility standards Date: 10. May 2016 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - gynaecology
Reference 04274/15

Urgent field safety notice for Cleaner A, DiaSys Diagnostic Systems GmbH PDF, 55KB, File does not meet accessibility standards Date: 10. May 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 02332/16

Lot recall of various sterile-packaged knee and hip implants, Zimmer Biomet PDF, 466KB, File does not meet accessibility standards Date: 10. May 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 03908/16

Urgent field safety notice for Revolution CT, GE Healthcare PDF, 160KB, File does not meet accessibility standards Date: 10. May 2016 Topics: Medical devices Type: Customer information

Product group Radiological technology - CT scanners
Reference 03911/16

Batch recall of R3° 0 Degree XLPE Acetabular Liner 32 mm ID X OD 48 mm, Smith & Nephew Inc. PDF, 79KB, File does not meet accessibility standards Date: 10. May 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 03871/16

Recall of Normed Fender Titanium Plates, Zimmer Biomet PDF, 108KB, File does not meet accessibility standards Date: 10. May 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 03733/16

Urgent field safety notice for FOX wheelchair, INVACARE PDF, 56KB, File does not meet accessibility standards Date: 10. May 2016 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology - mobility aids
Reference 02800/16

Urgent field safety notice for Biograph TruePoint systems running PETsyngo 6.7.x software / Biograph mCT and mCT Flow systems, Siemens PDF, 75KB, File does not meet accessibility standards Date: 09. May 2016 Topics: Medical devices Type: Customer information

Product group Radiological technology - CT scanners
Reference 03748/16

Recall of lntegra 3 micromanipulator, Research Instruments Limited PDF, 418KB, File does not meet accessibility standards Date: 09. May 2016 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - medical microscopes (does not incude laboratory microscopes)
Reference 02630/16

Urgent Field Safety Notice for ENCOR probes, Bard Limited PDF, 83KB, File does not meet accessibility standards Date: 09. May 2016 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 03680/16

Lot recall for Delicot, American Surgical Company PDF, 146KB, File does not meet accessibility standards Date: 09. May 2016 Topics: Medical devices Type: Customer information

Product group Dressings / Pads - swabs, sponges, wipes, swabsticks
Reference 03826/16

Urgent field safety notice for AU system, Beckman Coulter PDF, 267KB, File does not meet accessibility standards Date: 09. May 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 03830/16, 03831/16

Lot recall for ARCHITECT STAT High Sensitive Troponin-I, Abbott Ireland Diagnostics Division PDF, 38KB, File does not meet accessibility standards Date: 09. May 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 03679/16