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Corrective action for Integrated Digital Pathology System Software, version DPS 1.1, Omnyx PDF, 64KB, File does not meet accessibility standards Date: 12. November 2013 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) - others
Reference 05907/13

Safety Notice for LIFE 18 apheresis system, Miltenyi Biotec PDF, 127KB, File does not meet accessibility standards Date: 12. November 2013 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - therapeutic apheresis procedures
Reference 05577/13

Lot recall of Inflation device REF 2080-9030020 LOT 1210127, Spiggle & Theis Medizintechnik GmbH PDF, 360KB, File does not meet accessibility standards Date: 06. November 2013 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 01683/13

Corrective action for Indiko, Indiko Plus, Gallery, Gallery Plus und Gallery Plus Beer Master Analyzers, ThermoFisher PDF, 104KB, File does not meet accessibility standards Date: 05. November 2013 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 05406/13

Corrective action for BacT / Alert FA Plus Culture Bottles, BioMerieux PDF, 109KB, File does not meet accessibility standards Date: 05. November 2013 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 05321/13

Corrective action for Immulite / Immulite 1000, Immulite 2000 / Immulite 2000 XPI Free T3 Assays, Siemens PDF, 133KB, File does not meet accessibility standards Date: 05. November 2013 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 05222/13

Corrective action for ADAMS A1c Calibrator 80, Arkray PDF, 227KB, File does not meet accessibility standards Date: 05. November 2013 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 04604/13

Corrective action for Mueller Hinton 2 Agar, bioMérieux PDF, 120KB, File does not meet accessibility standards Date: 05. November 2013 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 04222/13

Field Safety Notice concerning Digital Linear Accelerators ONCOR and ARTISTE, Siemens Healthcare PDF, 66KB, File does not meet accessibility standards Date: 04. November 2013 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiation facilites with accelerators for teletherapy
Reference 06455/13

New checklist for STERRAD Boosters and Adapters before and after STERRAD sterilization cycle, Advanced Sterilization Products PDF, 84KB, File does not meet accessibility standards Date: 04. November 2013 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - cleaning / disinfection / sterilisation
Reference 05917/13

Field Safety Notice concerning Medumat Transport ventilator, Weinmann PDF, 72KB, File does not meet accessibility standards Date: 04. November 2013 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 07568/12

Corrective action for Xevo TQ-S Mass Spectrometers, Waters PDF, 639KB, File does not meet accessibility standards Date: 04. November 2013 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 05295/13

Corrective action for Easy Link Data Management Systems, Siemens PDF, 101KB, File does not meet accessibility standards Date: 31. October 2013 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 05193/13

Corrective action for HemoCue Glucose 201 RT Microcuvettes, HemoCue PDF, 57KB, File does not meet accessibility standards Date: 31. October 2013 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 04584/13

Corrective action for Bond Polymer Refine Red Detection System and Chromoplex 1 Dual Detection for Bond, Leica Biosystems PDF, 228KB, File does not meet accessibility standards Date: 31. October 2013 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 04512/13

Recall of all rHead and uHead stem implants, SBI PDF, 56KB, File does not meet accessibility standards Date: 31. October 2013 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 05354/13

Corrective measures expanded for Vacutainers, Becton Dickinson PDF, 201KB, File does not meet accessibility standards Date: 31. October 2013 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion kits
Reference 05123/13

Corrective action for Berichrom Heparin, Siemens PDF, 72KB, File does not meet accessibility standards Date: 31. October 2013 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 04955/13

Corrective action for Oxoid Antimicrobial Susceptibility Testing Disc MEM10 Meropenem, Thermo Fisher PDF, 20KB, File does not meet accessibility standards Date: 31. October 2013 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 04951/13

Lot recall of OptEase retrievable vena cava filters (articles no. 466F210A und 466F210B), Cordis PDF, 301KB, File does not meet accessibility standards Date: 30. October 2013 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 06063/13

Lot recall of application devices by SFM Medical Devices GmbH, Octapaharma PDF, 77KB, File does not meet accessibility standards Date: 30. October 2013 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 04263/13

Lot recall of Prostaflow Prostatectomy Catheters PVC Latex, Coloplast PDF, 61KB, File does not meet accessibility standards Date: 30. October 2013 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 03767/13

Corrective action for Calcium CPC, Dialab PDF, 115KB, File does not meet accessibility standards Date: 30. October 2013 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 04994/13

Corrective action for Advia 2120/2120i, Advia Autoslide, Siemens PDF, 70KB, File does not meet accessibility standards Date: 30. October 2013 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 04983/13

Corrective action for Hemosil Synthasil APTT Reagent, Instrumentation Laboratory PDF, 76KB, File does not meet accessibility standards Date: 30. October 2013 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 04943/13

Corrective action for Oxoid Antimicrobial Susceptibility Testing Disc AMC3 Amoxicillin / Clavulanic acid, Thermo Fisher PDF, 20KB, File does not meet accessibility standards Date: 30. October 2013 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 04932/13

Field Safety Notice concerning Meducore Standard Defibrillator Monitoring System, Weinmann Emergency GmbH PDF, 73KB, File does not meet accessibility standards Date: 29. October 2013 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 05991/13

Lots recall of 200 mm EverFlexTM, ev3 Incorporated PDF, 143KB, File does not meet accessibility standards Date: 29. October 2013 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 05639/13

Field Safety Notice concerning an issue with the dose volume statistics calculation in COMPASS 3.0, IBA Dosimetrie GmbH PDF, 482KB, File does not meet accessibility standards Date: 29. October 2013 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - nuclear medical therapeutic equipment
Reference 05423/13

Field safety notice for slings (produced for ProLift S222 sitto-stand hoist), Novacare PDF, 845KB, File does not meet accessibility standards Date: 28. October 2013 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - ward equipment and equipment for emergency medical services
Reference 05604/13