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Urgent Field Safety Notice for Alinity hq Analyzer and Alinity hs Slide Maker Stainer Module by Abbott GmbH & Co. KG PDF, 136KB, File does not meet accessibility standards Date: 25. October 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 13035/18

Urgent Field Safety Notice for Atellica Solution by Siemens Healthcare Diagnostics Inc. Tarrytown PDF, 72KB, File does not meet accessibility standards Date: 25. October 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 12834/18

Urgent Field Safety Notice for Dimension Integrated Chemistry Systems by Siemens Healthcare Diagnostics, Inc PDF, 61KB, File does not meet accessibility standards Date: 25. October 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 12790/18

Urgent Field Safety Notice for QUADROX-i Neonatal Microporous Membrane Oxygenator by Maquet Cardiopulmonary AG PDF, 153KB, File does not meet accessibility standards Date: 25. October 2018 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 12945/18

Urgent Field Safety Notice for Shoulder arthroscopy plate for schaerer axis by Schaerer Medical AG PDF, 1MB, File does not meet accessibility standards Date: 25. October 2018 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 12703/18

Urgent Field Safety Notice for compass 530 Haltungs- / Bruststabilisator by Proxomed Medizintechnik GmbH PDF, 106KB, File does not meet accessibility standards Date: 25. October 2018 Topics: Medical devices Type: Customer information

Product group Physical therapy - massage / mobility devices
Reference 06173/18

Urgent Field Safety Notice for Dispenser Issues with Hematoxylin II and Horseradish Peroxidase reagents by Ventana Medical Systems, Inc PDF, 572KB, File does not meet accessibility standards Date: 25. October 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 10042/18

Urgent Field Safety Notice for Owren's PT by MediRox AB PDF, 479KB, File does not meet accessibility standards Date: 25. October 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 04992/16

Urgent Field Safety Notice for ClinRep UHPLC Komplettkit Antiepileptika by RECIPE Chemicals + Instruments GmbH PDF, 598KB, File does not meet accessibility standards Date: 25. October 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 10309/18

Urgent Field Safety Notice for XL t(3;3) GATA2/MECOM DF by MetaSystems Probes GmbH PDF, 165KB, File does not meet accessibility standards Date: 25. October 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 10654/18

Urgent Field Safety Notice for HistoCore Spectra CV by Leica Biosystems Nussloch GmbH PDF, 3MB, File does not meet accessibility standards Date: 25. October 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - instruments, apparatuses and systems
Reference 10584/18

Urgent Field Safety Notice for BioGX by BioGX BV PDF, 69KB, File does not meet accessibility standards Date: 25. October 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 09729/18

Urgent Field Safety Notice for Elecsys FT4 III by Roche Diagnostics GmbH PDF, 139KB, File does not meet accessibility standards Date: 25. October 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 11829/18

Urgent Field Safety Notice for ARCHITECT HAVAB-IgG by Abbott GmbH & Co. KG PDF, 112KB, File does not meet accessibility standards Date: 25. October 2018 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 12466/18

Urgent Field Safety Notice for BARD ePTFE Small Beading Vascular Graft Products by Bard Peripheral Vascular (BPV) PDF, 108KB, File does not meet accessibility standards Date: 24. October 2018 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 13199/18

Urgent Field Safety Notice for IV s.t. by ICU Medical Inc. PDF, 394KB, File does not meet accessibility standards Date: 24. October 2018 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion kits
Reference 13397/18

Urgent Field Safety Notice for THERMOSET Closed-Loop Injectable Delivery system by ICU Medical Inc. PDF, 389KB, File does not meet accessibility standards Date: 23. October 2018 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 13176/18

Urgent Field Safety Notice for TERMINAL UNIT BM O2 NF by Air Liquide Medical Systems PDF, 86KB, File does not meet accessibility standards Date: 23. October 2018 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 13114/18

Urgent Field Safety Notice for Artis zee biplane and Artis Q biplane by Siemens Healthcare GmbH Advanced Therapies PDF, 2MB, File does not meet accessibility standards Date: 22. October 2018 Topics: Medical devices Type: Customer information

Product group Radiological technology - radiological equipment for vascular diagnostics
Reference 13218/18

Urgent Field Safety Notice for Jarvik 2000 Heart JHI-001 by Jarvik Heart Inc. PDF, 124KB, File does not meet accessibility standards Date: 22. October 2018 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - artificial hearts
Reference 12786/18

Urgent Field Safety Notice for Parietex Comp Stomy by Sofradim (subsidiary of Covidien) PDF, 229KB, File does not meet accessibility standards Date: 19. October 2018 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 12882/18

Urgent Field Safety Notice for CardioMems Hospital and Patient Electronic System by S.. Jude Medical, Inc. - CardioMEMS PDF, 120KB, File does not meet accessibility standards Date: 18. October 2018 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - measuring devices and sensors
Reference 07155/18

Urgent Field Safety Notice for Cera Plug by Lifetech Scientific Co. LTD PDF, 3MB, File does not meet accessibility standards Date: 18. October 2018 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 12399/18

Urgent Field Safety Notice for Medical Air Ensure by Drägerwerk AG & Co. KGaA PDF, 2MB, File does not meet accessibility standards Date: 18. October 2018 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 10386/18

Urgent Field Safety Notice for Rapid Flap SpinDown Clamp by Biomet Orthopaedic LLC PDF, 622KB, File does not meet accessibility standards Date: 17. October 2018 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 13090/18

Urgent Field Safety Notice for Mon-a-Therm Foley catheters with temperature sens by Degania Silicone Ltd. PDF, 202KB, File does not meet accessibility standards Date: 17. October 2018 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 10854/18

Urgent Field Safety Notice for Cardiosave Hybrid/Rescue IABP by Maquet (vorher: Datascope Corp) PDF, 92KB, File does not meet accessibility standards Date: 17. October 2018 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 12179/18

Urgent Field Safety Notice for GENESIS II MIS DCF DISTAL CUTTING BLOCK by Smith & Nephew, Inc., PDF, 117KB, File does not meet accessibility standards Date: 16. October 2018 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 12942/18

Urgent Field Safety Notice for UV-Therapiesystem UV 7001 by Herbert Waldmann GmbH & Co. PDF, 105KB, File does not meet accessibility standards Date: 15. October 2018 Topics: Medical devices Type: Customer information

Product group Physical therapy - phototherapy
Reference 12175/18

Urgent Field Safety Notice for Drill, AO Coupling, Ø 3 mm for 13 mm screw by icotec ag PDF, 2MB, File does not meet accessibility standards Date: 15. October 2018 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 12880/18