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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

Safety Notice for syngo ® RT Therapist 4.2, Siemens Healthcare PDF, 49KB, File does not meet accessibility standards Date: 09. July 2012 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiation facilites with accelerators for teletherapy
Reference 04167/12

Recall for IMMULITE / IMMULITE 1000 Total T3 Kit, Siemens PDF, 56KB, File does not meet accessibility standards Date: 09. July 2012 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 03910/12

Safety Notice for the 23G EDGEPLUS™ non-valved trocar cannula, Alcon Laboratories Inc. PDF, 965KB, File does not meet accessibility standards Date: 09. July 2012 Topics: Medical devices Type: Customer information

Product group ophthalmological technology - equipment for ophthalmological therapeutics
Reference 03703/12

Safety Notice for the MultiDiagnost Eleva with cable swivel, Philips Healthcare PDF, 489KB, File does not meet accessibility standards Date: 09. July 2012 Topics: Medical devices Type: Customer information

Product group Radiological technology - stationary radiological equipment
Reference 04050/12

Safety Notice for the iPlan RT Dose version 4.1 treatment planning software, Brainlab AG PDF, 75KB, File does not meet accessibility standards Date: 06. July 2012 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Reference 03952/12

Safety Notice for the RayStation 2.5 and RayStation 2.5.1, RaySearch Laboratories PDF, 69KB, File does not meet accessibility standards Date: 06. July 2012 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Reference 03745/12

Lot Recall of the eccentrical Adaptor Taper of the SMR Shoulder System, Limacorporate PDF, 89KB, File does not meet accessibility standards Date: 06. July 2012 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 03923/12

Safety Notice for Spectra Optia Apheresis System, Terumo BCT PDF, 360KB, File does not meet accessibility standards Date: 05. July 2012 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - therapeutic apheresis procedures
Reference 03353/12

Corrective Action for Afinion AS100 Analyzer and Afinion CRP, Axis Shield PDF, 98KB, File does not meet accessibility standards Date: 05. July 2012 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 04152/12

Recall for the HD Autoclavable Camera Head, Olympus PDF, 47KB, File does not meet accessibility standards Date: 05. July 2012 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - endoscopes
Reference 04220/12