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Urgent field safety notice for Digitoxin Reagent, Roche Diagnostics PDF, 147KB, File does not meet accessibility standards Date: 22. April 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 03181/16

Urgent Field Safety Notice for Algovita Spinal Cord System Stimulators Implantable (IPG) and External / Trial (EPG), Algostim LLC PDF, 371KB, File does not meet accessibility standards Date: 20. April 2016 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - biostimulators
Reference 00688/16

Recall of PENTARAY catheters, Johnson & Johnson Medical NV/SA / Biosense Webster PDF, 300KB, File does not meet accessibility standards Date: 20. April 2016 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 03231/16

Urgent field safety notice for 360 TIBIAL AUGMENT, Biomet UK Ltd. / Zimmer Biomet PDF, 136KB, File does not meet accessibility standards Date: 20. April 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 02999/16

Urgent field safety notice for Etermis 2, Merz Pharmaceuticals GmbH PDF, 66KB, File does not meet accessibility standards Date: 20. April 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - materials for implants
Reference 02565/16

Urgent field safety notice for Analyst MD Software, SCIEX PDF, 281KB, File does not meet accessibility standards Date: 20. April 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - instruments, apparatuses and systems
Reference 03251/16

Urgent field safety notice for iChemVELOCITY Automated Urine Chemistry System using iChemVELOCITY Urine Chemistry Strips, Iris International / Beckman Coulter PDF, 108KB, File does not meet accessibility standards Date: 20. April 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 00205/16

Urgent field safety notice for SagiNova Control Software, Eckert & Ziegler BEBIG GmbH PDF, 166KB, File does not meet accessibility standards Date: 20. April 2016 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - nuclear medical therapeutic equipment
Reference 02442/16

Urgent field safety notice for Biolox Delta Ceramic Head 32mm, Biomet UK Ltd. PDF, 275KB, File does not meet accessibility standards Date: 19. April 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 02789/16

Urgent field safety notice for M2a 38mm Acetabular System, ZIMMER BIOMET PDF, 178KB, File does not meet accessibility standards Date: 19. April 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 03156/16

Urgent field safety notice for 21inch monitor arm for ARIETTA 60 and ARIETTA 70, Hitachi Ltd. PDF, 158KB, File does not meet accessibility standards Date: 19. April 2016 Topics: Medical devices Type: Customer information

Product group Ultrasonics - ultrasonic diagnostic equipment
Reference 02849/16

Urgent field safety notice for cobas EGFR Mutation Test v2 CE-IVD, Roche Diagnostics PDF, 146KB, File does not meet accessibility standards Date: 18. April 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 03028/16

Urgent field safety notice for Uni-Gold LUA Plus, Trinity Biotech PDF, 1MB, File does not meet accessibility standards Date: 18. April 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 03180/16

Lot recall of ROTEM platelet cuvettes, Tem Innovations GmbH PDF, 372KB, File does not meet accessibility standards Date: 18. April 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - instruments, apparatuses and systems
Reference 02521/16

Urgent field safety notice for Dimension Vista 500 and 1500 Intelligent Lab System, Siemens Healthcare Diagnostics Inc. PDF, 158KB, File does not meet accessibility standards Date: 18. April 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 02787/16

Urgent field safety notice for hypo- / hyperthermia units, Xenios AG PDF, 278KB, File does not meet accessibility standards Date: 18. April 2016 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 00464/16

Urgent field safety notice for Da Vinci S / Si / Xi Surgical Systems, INTUITIVE SURGICAL PDF, 126KB, File does not meet accessibility standards Date: 15. April 2016 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 02675/16

Batch recall of Stainless steel head Ø22 Medium Neck, Evolutis PDF, 283KB, File does not meet accessibility standards Date: 15. April 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 02580/16

Urgent field safety notice for CDI Blood Parameter Monitoring System 500 / BPM Sensor Head Assembly, TERUMO Europe NV PDF, 265KB, File does not meet accessibility standards Date: 15. April 2016 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 03081/16

Urgent field safety notice for ABX PENTRA 400 (version 5.0.8 or lower) and PENTRA C400 (version 1.1.2 or lower), HORIBA ABX SAS PDF, 414KB, File does not meet accessibility standards Date: 14. April 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 03055/16

Urgent field safety notice for ThinPrep 5000 Processor with Autoloader, Hologic Inc. PDF, 78KB, File does not meet accessibility standards Date: 14. April 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 03026/16

Urgent field safety notice for oneHbA1c IS INNOVASTAR, DiaSys Diagnostic Systems GmbH PDF, 141KB, File does not meet accessibility standards Date: 14. April 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 03017/16

Urgent field safety notice for Leksell Gamma Knife Perfexion and Leksell Gamma Knife Icon, Elekta Instrument AB PDF, 85KB, File does not meet accessibility standards Date: 14. April 2016 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Reference 02821/16

Urgent Field Safety Notice for Protura Robotic Patient Positioning Software, CIVCO Medical Solutions PDF, 262KB, File does not meet accessibility standards Date: 14. April 2016 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiation facilites with accelerators for teletherapy
Reference 02492/16

Urgent field safety notice for ADVIA Centaur CP, Siemens Healthcare Diagnostics Inc. PDF, 79KB, File does not meet accessibility standards Date: 14. April 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 02919/16

Urgent field safety notice for Duraloc Option LPW Poly Inserts, DePuy Synthes PDF, 137KB, File does not meet accessibility standards Date: 12. April 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 02983/16

Urgent Field Safety Notice for AQT90 FLEX Test Kit Boxes and CAL Cartridges, Radiometer PDF, 23KB, File does not meet accessibility standards Date: 12. April 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 01014/16

Lot recall of KAMRA ACI 7000 Corneal Inlays, AcuFocus Inc. PDF, 82KB, File does not meet accessibility standards Date: 12. April 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - other implants
Reference 01116/16

Lot recall of CA090 Direct Drive Clip Appliers, Applied Medical PDF, 439KB, File does not meet accessibility standards Date: 12. April 2016 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - visceral surgery
Reference 02842/16

Urgent field safety notice for Aisys family of anesthesia devices, GE Healthcare PDF, 162KB, File does not meet accessibility standards Date: 12. April 2016 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 02624/16