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Urgent Field Safety Notice for several GE Healthcare MRI systems with superconducting magnets by GE HEALTHCARE (TIANJIN) COMPANY LIMITED PDF, 195KB, File does not meet accessibility standards Date: 21. April 2022 Topics: Medical devices Type: Customer information

Product group Electromedical fields - equipment for MR tomography
Reference 02659/22

Urgent Field Safety Notice for MAIOREGEN by FINCERAMICA PDF, 2MB, File does not meet accessibility standards Date: 21. April 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 07442/22

Urgent Field Safety Notice for Getinge CM320-series by Getinge Disinfection AB PDF, 737KB, File does not meet accessibility standards Date: 21. April 2022 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - cleaning / disinfection / sterilisation
Reference 06779/22

Urgent Field Safety Notice for 0072/Precision by Arcoma AB PDF, 152KB, File does not meet accessibility standards Date: 21. April 2022 Topics: Medical devices Type: Customer information

Product group Radiological technology - stationary radiological equipment
Reference 12118/21

Urgent Field Safety Notice for SureForm Stapler by Intuitive Surgical, Inc. PDF, 713KB, File does not meet accessibility standards Date: 21. April 2022 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - general instruments
Reference 07553/22

Urgent Field Safety Notice for Advanta V12 Covered Stent by Atrium Medical Corporation Merrimack PDF, 950KB, File does not meet accessibility standards Date: 14. April 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 05543/22

Urgent Field Safety Notice for Hugo RAS Arm Cart Assembly by Covidien llc PDF, 428KB, File does not meet accessibility standards Date: 14. April 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 06456/22

Urgent Field Safety Notice for Esophageal/Rectal Temperature Probes by Philips Goldway (Shenzhen) Industrial Inc. PDF, 813KB, File does not meet accessibility standards Date: 12. April 2022 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 06602/22

Urgent Field Safety Notice for IN.PACT ADMIRAL Paclitaxel-Eluting PTA Balloon Catheter by Medtronic Ireland PDF, 59KB, File does not meet accessibility standards Date: 30. March 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 06872/22

Urgent Field Safety Notice for Biopsieprodukte by ADRIA S.R.L. PDF, 179KB, File does not meet accessibility standards Date: 30. March 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - syringes and cannulas
Reference 07212/21

Urgent Field Safety Notice for Morcellator 5-times-use-Model: moresolution V 2.0 by Trokamed GmbH PDF, 342KB, File does not meet accessibility standards Date: 30. March 2022 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - endoscopes
Reference 06645/22

Urgent Field Safety Notice for ALPS; DVR; Juggerloc; SnapShot by Biomet Orthopedics, LLC PDF, 769KB, File does not meet accessibility standards Date: 30. March 2022 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 05377/22

Urgent Field Safety Notice for Remel Culti-Loops Candida albicans ATCC 10231 by Thermo Fisher Scientific (Lenexa) PDF, 622KB, File does not meet accessibility standards Date: 30. March 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 06758/22

Urgent Field Safety Notice for GOT Multi C2F6 by Al.CHI.MI.A. SRL PDF, 3MB, File does not meet accessibility standards Date: 29. March 2022 Topics: Medical devices Type: Customer information

Product group ophthalmological technology - other medical devices for ophthalmological purposes
Reference 03244/22

Urgent Field Safety Notice for Getinge 9100-Series by Getinge Disinfection AB PDF, 839KB, File does not meet accessibility standards Date: 29. March 2022 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - cleaning / disinfection / sterilisation
Reference 05952/22

Urgent Field Safety Notice for PrisMax, V2 ROW PrisMax V3 ROW by Baxter Healthcare S. (Opfikon) PDF, 422KB, File does not meet accessibility standards Date: 29. March 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - dialysis technology
Reference 06643/22

Urgent Field Safety Notice for TENEO by Sirona Dental Systems GmbH PDF, 133KB, File does not meet accessibility standards Date: 25. March 2022 Topics: Medical devices Type: Customer information

Product group Dental products - dental treatment units
Reference 06628/22

Urgent Field Safety Notice for MR systems with Twinspeed by GE Medical Systems, LLC PDF, 110KB, File does not meet accessibility standards Date: 24. March 2022 Topics: Medical devices Type: Customer information

Product group Electromedical fields - equipment for MR tomography
Reference 05635/22

Urgent Field Safety Notice for syngo.via RT Image Suite by Siemens Healthcare GmbH, SYNGO (SY) PDF, 2MB, File does not meet accessibility standards Date: 24. March 2022 Topics: Medical devices Type: Customer information

Product group Radiological technology - CT scanners
Reference 05757/22

Urgent Field Safety Notice for Infant/Child SMART Pads Cartridge Adult SMART Pads by Philips Healthcare, Bothell PDF, 3MB, File does not meet accessibility standards Date: 24. March 2022 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 05188/22

Urgent Field Safety Notice for Revolution CT by GE Medical Systems LLC PDF, 248KB, File does not meet accessibility standards Date: 22. March 2022 Topics: Medical devices Type: Customer information

Product group Radiological technology - CT scanners
Reference 05982/22

Urgent Field Safety Notice for Bexen Cardio Paediatric Pads for Defibrillation by FIAB SpA PDF, 216KB, File does not meet accessibility standards Date: 22. March 2022 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 05947/22

Urgent Field Safety Notice for HemosIL AcuStar ADAMTS13-Activity Assay by Instrumentation Laboratory Co. PDF, 203KB, File does not meet accessibility standards Date: 22. March 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 04426/22

Urgent Field Safety Notice for COMPELLA SCALE RENTAL by Hill-Rom Company, Inc. PDF, 180KB, File does not meet accessibility standards Date: 22. March 2022 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - furnishings
Reference 04230/22

Urgent Field Safety Notice for AlboGraft Polyester Vascular Graft by LeMaitre Vascular, Inc. PDF, 946KB, File does not meet accessibility standards Date: 22. March 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 04068/22

Urgent Field Safety Notice for Atellica IM/ADVIA Centaur Enhanced Estradiol (eE2) by Siemens Healthcare Diagnostics Inc. Tarrytown PDF, 50KB, File does not meet accessibility standards Date: 22. March 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 05735/22

Urgent Field Safety Notice for ARCHITECT S.A. Myoglobin Calibrators by Abbott Laboratories (Abbott Park) PDF, 147KB, File does not meet accessibility standards Date: 22. March 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 05738/22

Urgent Field Safety Notice for LumiraDx Platform Instrument V5E by LumiraDx UK Ltd PDF, 349KB, File does not meet accessibility standards Date: 22. March 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 05593/22

Urgent Field Safety Notice for FRED easyport plus by Schiller AG PDF, 314KB, File does not meet accessibility standards Date: 22. March 2022 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 05384/22

Urgent Field Safety Notice for Anti-ß2-Glykoprotein ELISA (IgAGM) by EUROIMMUN Medizinische Labordiagnostika AG PDF, 311KB, File does not meet accessibility standards Date: 22. March 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 05175/22