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Safety Information for the device HPA BeadChip Kit, Immucor Medizinische Diagnostik PDF, 31KB, File does not meet accessibility standards Date: 18. July 2012 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 01824/12

Corrective action of the AW Server picture archiving and communication system, GE Healthcare PDF, 131KB, File does not meet accessibility standards Date: 18. July 2012 Topics: Medical devices Type: Customer information

Product group Radiological technology - auxiliary equipment and supplies for radiology / nuclear medicine
Reference 04579/12

Recall of all lots of the applicator part AL07289000 Rectal Retractor, Stainless steel/white acetal, Varian Medical Systems PDF, 2MB, File does not meet accessibility standards Date: 18. July 2012 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - nuclear medical therapeutic equipment
Reference 04580/12

Lot Recall for Anti-Gangliosid Dot, GA Generic Assays GmbH PDF, 124KB, File does not meet accessibility standards Date: 17. July 2012 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 04419/12

Follow-up Information for the AcrySof® CACHET® Phakic Lens, Alcon PDF, 2MB, File does not meet accessibility standards Date: 17. July 2012 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 00724/12

Lot Recall for the the device “Apex Knee System Tibial Base Plate", OMNIlife science PDF, 34KB, File does not meet accessibility standards Date: 17. July 2012 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 03037/12

Field Safety Notice for Minstrel, Minerva, Gemini and Excelsior, ArjoHuntleigh PDF, 39KB, File does not meet accessibility standards Date: 17. July 2012 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - ward equipment and equipment for emergency medical services
Reference 03857/12

Lot Recall for Dimension Vista Vancomycin Flex reagent cartridge, Siemens Healthcare Diagnostics PDF, 90KB, File does not meet accessibility standards Date: 17. July 2012 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 04495/12

Safety Notice concerning a corrective action of the HeartStart MRx monitor/defibrillators, Philips Healthcare PDF, 51KB, File does not meet accessibility standards Date: 16. July 2012 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 04564/12

Safety Notice concerning a corrective action of the HeartStart MRx monitor/defibrillators, Philips Healthcare PDF, 151KB, File does not meet accessibility standards Date: 16. July 2012 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 04562/12

Corrective Action for STA Satellite, Diagnostica Stago PDF, 70KB, File does not meet accessibility standards Date: 16. July 2012 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 03469/12

Corrective Action for IMMULITE / IMMULITE 1000 Third Generation TSH, IMMULITE 2000 Rapid TSH / IMMULITE 2000 XPi Rapid TSH and IMMULITE 2500 Rapid TSH, Siemens PDF, 99KB, File does not meet accessibility standards Date: 16. July 2012 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 04378/12

Safety Notice for Silentia bed-screens, Silentia AB PDF, 419KB, File does not meet accessibility standards Date: 16. July 2012 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - furnishings
Reference 04427/12

Corrective Action for ABL80 FLEX and ABL80 FLEX CO-OX analyzers, Radiometer PDF, 92KB, File does not meet accessibility standards Date: 13. July 2012 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 03880/12

Software update for Intellispace Portal with software version 4.0 and 4.0.1, Philips Healtcare PDF, 212KB, File does not meet accessibility standards Date: 13. July 2012 Topics: Medical devices Type: Customer information

Product group Radiological technology - CT scanners
Reference 04067/12

Safety Notice for the digital linear accelerators of type ARTISTE™ and ONCOR™, Siemens Healthcare PDF, 50KB, File does not meet accessibility standards Date: 12. July 2012 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiation facilites with accelerators for teletherapy
Reference 04455/12

Safety Information for the Aviator drill, Stryker Spine PDF, 52KB, File does not meet accessibility standards Date: 12. July 2012 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 04379/12

Urgent Safety Notice for the Equinoxe Shoulder System, Exactech, Inc. PDF, 151KB, File does not meet accessibility standards Date: 12. July 2012 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 04385/12

Safety Notice regarding CONCHATHERM® NEPTUNE™HEATED HUMIDIFIER, Teleflex PDF, 94KB, File is accessible Date: 12. July 2012 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 04055/12

Safety Notice for the Intellispace Portal (ISP) Multi-Modality Tumor Tracking application with software version 4.0.1, Philips Healtcare PDF, 196KB, File does not meet accessibility standards Date: 11. July 2012 Topics: Medical devices Type: Customer information

Product group Radiological technology - CT scanners
Reference 04068/12

Safety Notice for the OCS - Heart device, TransMedics PDF, 195KB, File does not meet accessibility standards Date: 11. July 2012 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 04015/12

Safety Notice concerning a problem with Autoclave HMT 232X, Sturdy Industrial PDF, 101KB, File does not meet accessibility standards Date: 11. July 2012 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - cleaning / disinfection / sterilisation
Reference 05454/11

Safety Notice for the Ardo Amemnc radiant lamp, Ardo medical AG PDF, 64KB, File does not meet accessibility standards Date: 11. July 2012 Topics: Medical devices Type: Customer information

Product group Physical therapy - climatotherapy
Reference 01976/12

Corrective Action for Cholestech LDX, Alere PDF, 48KB, File does not meet accessibility standards Date: 11. July 2012 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 03853/12

Corrective Action / Follow-up Information for CA19-9 Flex reagent cartridges, Siemens PDF, 294KB, File does not meet accessibility standards Date: 10. July 2012 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 03498/12

Safety Notice for the Philips Xcelera Connect R2.1L1 SP2, Philips Healthcare PDF, 578KB, File does not meet accessibility standards Date: 10. July 2012 Topics: Medical devices Type: Customer information

Product group Radiological technology - auxiliary equipment and supplies for radiology / nuclear medicine
Reference 04376/12

Reformat Image Flip Issue associated with MRI Systems, GE Healthcare PDF, 36KB, File does not meet accessibility standards Date: 10. July 2012 Topics: Medical devices Type: Customer information

Product group Electromedical fields - equipment for MR tomography
Reference 04466/12

Corrective Action for Stratus CS Acute Care D-Dimer CalPak Calibrator, Siemens PDF, 24KB, File does not meet accessibility standards Date: 09. July 2012 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 03990/12