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Safety Notice for Gliding Nail Blade Handle, SMITH&NEPHEW PDF, 82KB, File does not meet accessibility standards Date: 22. February 2012 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 00451/12

Software-Update of the treadmills of the PPS Series, Woodway GmbH PDF, 211KB, File does not meet accessibility standards Date: 21. February 2012 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - functional diagnostics by way of gas exchange and exercise
Reference 00158/11

Corrective Action of specific Trilogy Ventilators, Philips Respironics PDF, 24KB, File does not meet accessibility standards Date: 21. February 2012 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 00460/12

Lot Recall for the Hedstroem root canal file, HAGER & MEISINGER PDF, 88KB, File does not meet accessibility standards Date: 21. February 2012 Topics: Medical devices Type: Customer information

Product group Dental products - instruments
Reference 00012/12

Incorrect position readout values caused by excessive connector resistance of C-Series Clinac® Models, Varian medical systems PDF, 206KB, File does not meet accessibility standards Date: 17. February 2012 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiation facilites with accelerators for teletherapy
Reference 00805/12

Lot recall of cardiac guide wire, OptiMed Medizinische Instrumente GmbH PDF, 650KB, File does not meet accessibility standards Date: 17. February 2012 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 00776/12

Recall of all articles of cyclOS Putty, MATHYS European Orthopaedics PDF, 198KB, File does not meet accessibility standards Date: 17. February 2012 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 00774/12

Recall of Masstrak Immunosuppressants XE RUO Kit, Waters PDF, 103KB, File does not meet accessibility standards Date: 17. February 2012 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 00743/12

Recall of all unexpired lots of „S.M.A.R.T. CONTROL“ Nitinol Stent System, Cordis PDF, 162KB, File does not meet accessibility standards Date: 17. February 2012 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 00629/12

Field safety notice for VariSeed users, Varian Medical systems PDF, 178KB, File does not meet accessibility standards Date: 17. February 2012 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - nuclear medical therapeutic equipment
Reference 00530/12

Corrective Action for IMMULITE CK-MB, Siemens PDF, 71KB, File does not meet accessibility standards Date: 17. February 2012 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 00504/12

Recall of ATB ANA EU Kit, BioMerieux PDF, 234KB, File does not meet accessibility standards Date: 17. February 2012 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 00452/12

Recall of Active Renin IRMA Test Kit, Beckman Coulter PDF, 29KB, File does not meet accessibility standards Date: 17. February 2012 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 00420/12

Corrective Action for clinical Chemistry Analyzers AU2700 / AU2700 Plus and AU5400, Beckman Coulter PDF, 135KB, File does not meet accessibility standards Date: 17. February 2012 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 00389/12

Corrective Action for primary antibodies to CD2 and CD7, Leica Biosystems PDF, 299KB, File does not meet accessibility standards Date: 17. February 2012 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 00364/12

Corrective Action for Dimension Vista Systems Software Version 3.4, Siemens PDF, 31KB, File does not meet accessibility standards Date: 17. February 2012 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 06034/11

Failure in XVI, Elekta PDF, 237KB, File does not meet accessibility standards Date: 16. February 2012 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiation facilites with accelerators for teletherapy
Reference 00356/12

Batch recall of SUSI Instruments because of potential insterility, Aesculap AG PDF, 168KB, File does not meet accessibility standards Date: 16. February 2012 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - general instruments
Reference 00807/12

Safety issue with 4D Planning procedure option of MultiPlan® Treatment Planning System, Accuray PDF, 318KB, File does not meet accessibility standards Date: 15. February 2012 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Reference 00673/12

Error in software catalog number 71070401 for external fixator Spatial Frame, Smith & Nephew Orthopaedics GmbH PDF, 82KB, File does not meet accessibility standards Date: 15. February 2012 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) - others
Reference 00580/12

Software update for Leica M822 F20 and M822 F40 surgical microscopes required, Leica Microsystems PDF, 111KB, File does not meet accessibility standards Date: 15. February 2012 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - medical microscopes (does not incude laboratory microscopes)
Reference 00400/12

Potential defect of the AC/draw/return manifold of Trima Accel Disposable Tubing Sets, CaridianBCT PDF, 222KB, File does not meet accessibility standards Date: 15. February 2012 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - equipment for collecting blood products and peripheral stem cells
Reference 00082/12

Potential of wrong patient images when reviewing images on LOGIQ S8 Ultrasound System, GE Healthcare PDF, 58KB, File does not meet accessibility standards Date: 14. February 2012 Topics: Medical devices Type: Customer information

Product group Ultrasonics - ultrasonic diagnostic equipment
Reference 00713/12

Possibility of probe heads on LOGIQ P6 Ultrasound Systems for heating up, GE Healthcare PDF, 50KB, File does not meet accessibility standards Date: 14. February 2012 Topics: Medical devices Type: Customer information

Product group Ultrasonics - ultrasonic diagnostic equipment
Reference 00672/12

Recall of Creatinine PAP FS (Lot No.: 15317) due to deviating results, DiaSys PDF, 66KB, File does not meet accessibility standards Date: 14. February 2012 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 00667/12

Possible stuck or hard to turn Pump speed control knob, Sorin Group PDF, 657KB, File does not meet accessibility standards Date: 14. February 2012 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 00505/12

Batch recall of gauze swabs with x-ray thread, Karl Beese GmbH PDF, 849KB, File does not meet accessibility standards Date: 13. February 2012 Topics: Medical devices Type: Customer information

Product group Dressings / Pads - swabs, sponges, wipes, swabsticks
Reference 00678/12

Software update for implantable drug infusion pumps model 91-4200 and 91-4201, Codman PDF, 51KB, File does not meet accessibility standards Date: 13. February 2012 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - drug pumps
Reference 00500/12

Field Safety Notice concerning revised instruction for use of mattress model NP 150, Hill Rom PDF, 132KB, File does not meet accessibility standards Date: 13. February 2012 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - furnishings
Reference 00481/12

Corrective action for COULTER PrepPlus, Beckman Coulter PDF, 93KB, File does not meet accessibility standards Date: 13. February 2012 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - instruments, apparatuses and systems
Reference 00458/12