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Urgent Field Safety Notice for Cardioband by Edwards Cardioband PDF, 877KB, File does not meet accessibility standards Date: 22. August 2018 Topics: Medical devices Type: Customer information

Product group Non-active implants - cardiac surgery
Reference 10548/18

Urgent Field Safety Notice for ADVIA Centuar CKMB Calibrator/Atellica CKMB Calibrator by Siemens Healthcare Diagnostics Inc. Tarrytown PDF, 423KB, File does not meet accessibility standards Date: 22. August 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 09663/18

Urgent Field Safety Notice for Ergo Just Cart by Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) PDF, 179KB, File does not meet accessibility standards Date: 22. August 2018 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - ENT equipment
Reference 06010/18

Urgent Field Safety Notice for DORO LUCENT Base Unit by PMI pro med Instruments GmbH PDF, 12MB, File does not meet accessibility standards Date: 22. August 2018 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 08268/18

Urgent Field Safety Notice for Drill CS 2.7/3.5, ø2.7, L 130, quick coupling by aap Implantate AG PDF, 710KB, File does not meet accessibility standards Date: 21. August 2018 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 10505/18

Urgent Field Safety Notice for Transplant-Aspiration Needle, SPI-CUT by Somatex Medical Technologies GmbH / Berlin PDF, 361KB, File does not meet accessibility standards Date: 21. August 2018 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - general instruments
Reference 10510/18

Urgent Field Safety Notice for AST-P640 Test Kit and AST-P655 Test Kit by bioMérieux Inc PDF, 383KB, File does not meet accessibility standards Date: 21. August 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 10455/18

Urgent Field Safety Notice for Rotating IV pole by GE Healthcare Clinical Systems (Ohmeda Medical) PDF, 381KB, File does not meet accessibility standards Date: 21. August 2018 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 10518/18

Urgent Field Safety Notice for Output Unit by Hitachi, Ltd. PDF, 101KB, File does not meet accessibility standards Date: 21. August 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 04106/17

Urgent Field Safety Notice for Oxoid CT0159B by Remel Europe. Part of Thermo Fisher Scientific PDF, 86KB, File does not meet accessibility standards Date: 21. August 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 05700/18

Urgent Field Safety Notice for RAPIDPoint 405 500 and RAPIDLab 1245 1265 by Siemens Healthcare Diagnostics Inc. Tarrytown PDF, 66KB, File does not meet accessibility standards Date: 21. August 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 09283/18

Urgent Field Safety Notice for 611P CT Lucia by Carl-Zeiss-Meditec AG PDF, 217KB, File does not meet accessibility standards Date: 21. August 2018 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 09981/18

Urgent Field Safety Notice for Minicon Clinical Sample Concentrators by Merck Millipore Ltd PDF, 60KB, File does not meet accessibility standards Date: 21. August 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 06679/18

Urgent Field Safety Notice for cobas m 511 integrated hematology analyzer by Roche Diagnostics GmbH PDF, 739KB, File does not meet accessibility standards Date: 21. August 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 05666/18

Urgent Field Safety Notice for ARCHITECT EBV VCA IgM Controls by Abbott GmbH & Co.KG PDF, 100KB, File does not meet accessibility standards Date: 21. August 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 09310/18

Urgent Field Safety Notice for power supply for div. sleep therapy devices by Löwenstein Medical Technology GmbH + Co. KG PDF, 115KB, File does not meet accessibility standards Date: 21. August 2018 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 09532/18

Urgent Field Safety Notice for Endocavity Needle Guide by CIVCO Medical Instruments Co., Inc. d.b.a CIVCO Medical Solutions PDF, 71KB, File does not meet accessibility standards Date: 20. August 2018 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - cardiac/thorax surgery
Reference 10372/18

Urgent Field Safety Notice for Direct Radiography system DX-D 600 by Agfa HealthCare N.V. PDF, 187KB, File does not meet accessibility standards Date: 20. August 2018 Topics: Medical devices Type: Customer information

Product group Radiological technology - stationary radiological equipment
Reference 10051/18

Urgent Field Safety Notice for ZNN TIBIAL NAIL by Zimmer Biomet, Inc. Warsaw PDF, 307KB, File does not meet accessibility standards Date: 20. August 2018 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 10159/18

Urgent Field Safety Notice for AIRO Mobile CT System by Mobius Imaging, LLC PDF, 340KB, File does not meet accessibility standards Date: 20. August 2018 Topics: Medical devices Type: Customer information

Product group Radiological technology - CT scanners
Reference 09932/18

Urgent Field Safety Notice for Allura Xper and Integris Allura Systems by Philips Medical Systems Nederland B.V. PDF, 229KB, File does not meet accessibility standards Date: 20. August 2018 Topics: Medical devices Type: Customer information

Product group Radiological technology - radiological equipment for vascular diagnostics
Reference 10311/18

Urgent Field Safety Notice for MiniMed remote controller by Medtronic Minimed PDF, 134KB, File does not meet accessibility standards Date: 20. August 2018 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 10052/18

Urgent Field Safety Notice for ECO Bath by CareNow Medical Pvt. Ltd. PDF, 256KB, File does not meet accessibility standards Date: 20. August 2018 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 10065/18

Urgent Field Safety Notice for Miele Sterilisatoren by Miele & Cie. KG PDF, 2MB, File does not meet accessibility standards Date: 20. August 2018 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - cleaning / disinfection / sterilisation
Reference 02863A/18

Urgent Field Safety Notice for Miele Sterilisatoren by Miele & Cie. KG PDF, 3MB, File does not meet accessibility standards Date: 20. August 2018 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - cleaning / disinfection / sterilisation
Reference 02863/18

Urgent Field Safety Notice for MobileDiagnost wDR by Philips Medical Systems DMC GmbH PDF, 56KB, File does not meet accessibility standards Date: 20. August 2018 Topics: Medical devices Type: Customer information

Product group Radiological technology - stationary radiological equipment
Reference 08200/18

Urgent Field Safety Notice for 611P CT Lucia by Carl-Zeiss-Meditec AG PDF, 245KB, File does not meet accessibility standards Date: 20. August 2018 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 00996/18

Urgent Field Safety Notice for sterEOS workstation by EOS imaging PDF, 307KB, File does not meet accessibility standards Date: 20. August 2018 Topics: Medical devices Type: Customer information

Product group Radiological technology - auxiliary equipment and supplies for radiology / nuclear medicine
Reference 09734/18

Urgent Field Safety Notice for MetaVision Suite, Clinical Information System& EHR by iMDsoft Ltd. PDF, 294KB, File does not meet accessibility standards Date: 20. August 2018 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) - others
Reference 09574/18

Urgent Field Safety Notice for Durex "Real Feel" Polyisoprene Condoms by Reckitt Benckiser Healthcare International PDF, 87KB, File does not meet accessibility standards Date: 20. August 2018 Topics: Medical devices Type: Customer information

Product group Contraception - condoms
Reference 09486/18