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Urgent field safety notice for Innova 2100IQ / 3100 / 3100IQ / 4100 / 4100IQ, GE Healthcare PDF, 428KB, File does not meet accessibility standards Date: 27. October 2016 Topics: Medical devices Type: Customer information

Product group Radiological technology - radiological equipment for vascular diagnostics
Reference 09104/16

Urgent field safety notice for IACS SW Version VG5.0, Draeger Medical Systems Inc. PDF, 122KB, File does not meet accessibility standards Date: 27. October 2016 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 09087/16

Urgent field safety notice for Biosen Glucose / Lactate Consumables, EKF-diagnostic GmbH PDF, 144KB, File does not meet accessibility standards Date: 26. October 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 09040/16

Lot recall of LASEREDGE 1.5 mm x 1.7 mm Trapezoid Angled 6 / Box, Bausch+Lomb OPS B.V. / Valeant Pharmaceuticals International Inc. PDF, 218KB, File does not meet accessibility standards Date: 26. October 2016 Topics: Medical devices Type: Customer information

Product group ophthalmological technology - equipment for ophthalmological therapeutics
Reference 08062/16

Urgent field safety notice for boso TM-2430 PC2, Bosch + Sohn GmbH u. Co. KG PDF, 13KB, File does not meet accessibility standards Date: 26. October 2016 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electronic blood pressure monitor
Reference 08050/16

Lot recall of DRI Salicylate Serum Tox Assay, Thermo Fisher Scientific / Microgenics GmbH PDF, 394KB, File does not meet accessibility standards Date: 26. October 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 06611/16

Urgent field safety notice for GLU / LAC / UREA (BUN) Cassette, Roche Diagnostics GmbH PDF, 77KB, File does not meet accessibility standards Date: 25. October 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 08808/16

Urgent field safety notice for Prometra programmable pump (REF 91827), Flowonix Medical Inc. PDF, 344KB, File does not meet accessibility standards Date: 25. October 2016 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - drug pumps
Reference 06615/16

Urgent field safety notice for central axis system, S.I.M.E.O.N. PDF, 353KB, File does not meet accessibility standards Date: 24. October 2016 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 05912/16

Urgent field safety notice for CPX4 Medium Height Breast Tissue Expander 650 cc, Mentor PDF, 126KB, File does not meet accessibility standards Date: 24. October 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 06921/16

Urgent field safety notice for Brilliance 64 and Ingenuity CT / Core / Core128, Philips Healthcare PDF, 127KB, File does not meet accessibility standards Date: 24. October 2016 Topics: Medical devices Type: Customer information

Product group Radiological technology - CT scanners
Reference 08188/16

Urgent field safety notice for Chemistry Calibrator, Siemens Healthcare Diagnostics Inc. PDF, 84KB, File does not meet accessibility standards Date: 24. October 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 08861/16

Lot recall of PATHFAST Myoglobin, Mitsubishi Chemical Europe GmbH PDF, 121KB, File does not meet accessibility standards Date: 24. October 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 08690/16

Lot recall of NADAL RSV rapid test, nal von minden GmbH PDF, 277KB, File does not meet accessibility standards Date: 24. October 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 08874/16

Urgent field safety notice for Heater Unit HU 35 and Heater-Cooler Unit HCU 20 / 30 / 40, Maquet Cardiopulmonary GmbH PDF, 388KB, File does not meet accessibility standards Date: 20. October 2016 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 07301/16

Lot recall of SelectiCure L19, 3M Deutschland GmbH PDF, 154KB, File does not meet accessibility standards Date: 20. October 2016 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - dialysis technology
Reference 08856/16

Urgent field safety notice for FACET WEDGE, DePuy Synthes / Synthes GmbH PDF, 278KB, File does not meet accessibility standards Date: 20. October 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 08844/16

Recall of IBS-TITAN TLIF II, Peter Brehm GmbH PDF, 154KB, File does not meet accessibility standards Date: 19. October 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 08831/16

Urgent field safey notice for Dialog+ Dialysis Machines with Software 8.2A, B. Braun PDF, 36KB, File does not meet accessibility standards Date: 19. October 2016 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - dialysis technology
Reference 08784/16

Batch recall of ORG 908MX Anti Mumps Virus IgM, ORGENTEC Diagnostika GmbH PDF, 234KB, File does not meet accessibility standards Date: 19. October 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 07067/16

Urgent field safety notice for Devon Light Glove, Medtronic / Covidien PDF, 374KB, File does not meet accessibility standards Date: 19. October 2016 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 08802/16

Urgent field safety notice for Devon Light Glove, Medtronic / Covidien PDF, 183KB, File does not meet accessibility standards Date: 19. October 2016 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 08458/16

Urgent field safety notice for ARCHITECT Lactic Acid reagent, Abbott Laboratories PDF, 26KB, File does not meet accessibility standards Date: 19. October 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 08653/16

Urgent field safety notice for Algovita Spinal Cord Stimulation System, Nuvectra PDF, 357KB, File does not meet accessibility standards Date: 19. October 2016 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - biostimulators
Reference 08794/16

Lot recall of Reducer Kit, Neovasc PDF, 26KB, File does not meet accessibility standards Date: 18. October 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 08741/16

Lot recall of gabControl D-Dimer rapid test (M09DD02), gabmed GmbH PDF, 146KB, File does not meet accessibility standards Date: 18. October 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 08815/16

Urgent field safety notice for IntelliVue MX40, Philips Healthcare PDF, 236KB, File does not meet accessibility standards Date: 18. October 2016 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 08747/16

Batch recall of AV-Set B-R, Fresenius Medical Care PDF, 36KB, File does not meet accessibility standards Date: 18. October 2016 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - dialysis technology
Reference 08806/16

Urgent field safety notice for Combi Dockable Table Neurosurgery, Siemens Healthcare GmbH PDF, 222KB, File does not meet accessibility standards Date: 18. October 2016 Topics: Medical devices Type: Customer information

Product group Electromedical fields - equipment for MR tomography
Reference 08759/16