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Urgent Field Safety Notice for Instrument Manager Software by Data Innovations LLC PDF, 99KB, File does not meet accessibility standards Date: 04. October 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 11799/18

Urgent Field Safety Notice for Slide Labeler (Zebra) used with BOND-MAX/BOND-III by Leica Biosystems Melbourne Pty Ltd PDF, 2MB, File does not meet accessibility standards Date: 04. October 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - instruments, apparatuses and systems
Reference 11360/18

Urgent Field Safety Notice for CyPass System by Alcon Laboratories, Inc. PDF, 105KB, File does not meet accessibility standards Date: 04. October 2018 Topics: Medical devices Type: Customer information

Product group Non-active implants - other implants
Reference 11047/18

Urgent Field Safety Notice for DRILL BIT by Orthofix SRL PDF, 3MB, File does not meet accessibility standards Date: 02. October 2018 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 11993/18

Urgent Field Safety Notice for Millennium MG, Millennium MC, Millennium MYOSIG by GE Medical Systems Israel, Functional Imaging PDF, 493KB, File does not meet accessibility standards Date: 02. October 2018 Topics: Medical devices Type: Customer information

Product group Radiological technology - equipment for nuclear medical functional and localisation diagnostics
Reference 11938/18

Urgent Field Safety Notice for Silk+ by BALT Extrusion PDF, 356KB, File does not meet accessibility standards Date: 02. October 2018 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 12010/18

Urgent Field Safety Notice for Mon-a-ThermT Foley catheters with temperature sensors by Mölnlycke Health Care AB PDF, 309KB, File does not meet accessibility standards Date: 02. October 2018 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 12316/18

Urgent Field Safety Notice for BRONCHOSKOP-TUBUS by Richard Wolf GmbH PDF, 218KB, File does not meet accessibility standards Date: 02. October 2018 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 11894/18

Urgent Field Safety Notice for DrillSaw Sports 400 System Li-Ion Battery Housing by Arthrex INC PDF, 357KB, File does not meet accessibility standards Date: 02. October 2018 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 10918/18

Urgent Field Safety Notice for HydroSet Injectable HA Bone Substitute by Stryker Leibinger GmbH & Co. KG PDF, 418KB, File does not meet accessibility standards Date: 01. October 2018 Topics: Medical devices Type: Customer information

Product group Non-active implants - materials for implants
Reference 11678/18

Urgent Field Safety Notice for Activa PC Neurostimulator, Activa S. Multi-program Neurostimulator, Activa PC+S, Activa RC Multi-Program Rechargable Neurostimulator by Medtronic Inc PDF, 48KB, File does not meet accessibility standards Date: 01. October 2018 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - biostimulators
Reference 10990/18

Urgent Field Safety Notice for Impella 2.5 Herzpumpe, Impella CP Herzpumpe by Abiomed Europe GmbH PDF, 87KB, File does not meet accessibility standards Date: 01. October 2018 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 12352/18

Urgent Field Safety Notice for 220-240V Unit Cable (power cord) by B. Braun Melsungen AG PDF, 119KB, File does not meet accessibility standards Date: 26. September 2018 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 11670/18

Urgent Field Safety Notice for Single-Use, Colpo-Pneumo Occluder by Cooper Surgical Inc. PDF, 232KB, File does not meet accessibility standards Date: 25. September 2018 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - gynaecology
Reference 11711/18

Urgent Field Safety Notice for ekamove 30°Seitenlagerungssystem (HIMI:11.29.1003) by ekamed GmbH & Co. KG PDF, 1MB, File does not meet accessibility standards Date: 25. September 2018 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - furnishings
Reference 11657/18

Urgent Field Safety Notice for FlexLab by Inpeco SA PDF, 46KB, File does not meet accessibility standards Date: 25. September 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - instruments, apparatuses and systems
Reference 10914/18

Urgent Field Safety Notice for Calibrateur HDL LDL CK-MB ref 95506 & Sérum de contrôle HDL LDLCK-MB Lipides (ref 95516 & 95526) by BIOLABO PDF, 201KB, File does not meet accessibility standards Date: 25. September 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 11257/18

Urgent Field Safety Notice for PATHFAST by LSI Medience Corporation PDF, 521KB, File does not meet accessibility standards Date: 25. September 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 11379/18

Urgent Field Safety Notice for SIRSCAN® DISCS Amoxicilline 2µg +Acide clavulanique 1µg by I2A - Intelligence Artificielle Applications PDF, 319KB, File does not meet accessibility standards Date: 25. September 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 11281/18

Urgent Field Safety Notice for Dimension Lipase / Dimension Vista Lipase by Siemens Healthcare Diagnostics Inc. Newark PDF, 73KB, File does not meet accessibility standards Date: 25. September 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 11937/18

Urgent Field Safety Notice for GENESIS II NON POROUS C/R FEMORAL SIZE 6 RIGHT by Smith & Nephew Orthopaedics GmbH PDF, 115KB, File does not meet accessibility standards Date: 25. September 2018 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 09939/18

Urgent Field Safety Notice for Kaluza C Software version 1.0 by Beckman Coulter, Inc. PDF, 189KB, File does not meet accessibility standards Date: 25. September 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 12068/18

Urgent Field Safety Notice for Pastorex Meningitis by Bio-Rad Laboratories France PDF, 426KB, File does not meet accessibility standards Date: 25. September 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 11253/18

Urgent Field Safety Notice for Alinity i Processing Module by Abbott GmbH & Co. KG PDF, 90KB, File does not meet accessibility standards Date: 25. September 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 11838/18

Urgent Field Safety Notice for BD Micro-Fine Ultra by Becton Dickinson Franklin Lakes PDF, 115KB, File does not meet accessibility standards Date: 24. September 2018 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - insulin pens and pen cannulas
Reference 11988/18

Urgent Field Safety Notice for KURZ-Precise Schneideblock by Heinz Kurz GmbH Medizintechnik PDF, 170KB, File does not meet accessibility standards Date: 21. September 2018 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 11940/18

Urgent Field Safety Notice for O-ARM Imaging System by Medtronic Navigation Inc. PDF, 53KB, File does not meet accessibility standards Date: 21. September 2018 Topics: Medical devices Type: Customer information

Product group Radiological technology - navigation systems
Reference 11933/18

Urgent Field Safety Notice for HeartWare Ventricular Assist System by Heartware, Inc. PDF, 279KB, File does not meet accessibility standards Date: 21. September 2018 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - artificial hearts
Reference 11063/18

Urgent Field Safety Notice for CentriMag Blood Pumping System by Thoratec Corporation PDF, 642KB, File does not meet accessibility standards Date: 21. September 2018 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 11298/18