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Urgent Field Safety Notice for 20/30 INDEFLATORTM, INDEFLATORTM Plus 30 and Priority Packs by Abbott Vascular, Santa Clara PDF, 244KB, File does not meet accessibility standards Date: 21. March 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 05871/22

Urgent Field Safety Notice for Original and Essential Kit Pedicle Screw systems by Safe Orthopaedics PDF, 895KB, File does not meet accessibility standards Date: 18. March 2022 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 03807/22

Urgent Field Safety Notice for Ultima Activator II Reusable Drive Mech by Maquet Cardiovascular PDF, 287KB, File does not meet accessibility standards Date: 18. March 2022 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - cardiac/thorax surgery
Reference 03531/22

Urgent Field Safety Notice for NATURA LP57 HCA DURA CVXCTF13-35 1X5EUR by ConvaTec Limited Deeside PDF, 2MB, File does not meet accessibility standards Date: 18. March 2022 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology - care of natural and artificial body orifices
Reference 00418/22

Urgent Field Safety Notice for Diagnostic Package Pulse Oxymetry/Capnography by Imtmedical AG PDF, 324KB, File does not meet accessibility standards Date: 18. March 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 31491/21

Urgent Field Safety Notice for Nextra Hammertoe Correction System by Nextremity Solutions, Inc. PDF, 15MB, File does not meet accessibility standards Date: 18. March 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 05327/22

Urgent Field Safety Notice for SpaceOAR and SpaceOAR Vue Systems by Boston Scientific Corporation Marlborough PDF, 254KB, File does not meet accessibility standards Date: 18. March 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 04592/22

Urgent Field Safety Notice for Sonialvision Series (G4/Safire17/UD150B-40) by Shimadzu Corporation PDF, 102KB, File does not meet accessibility standards Date: 18. March 2022 Topics: Medical devices Type: Customer information

Product group Radiological technology - CT scanners
Reference 04848/22

Urgent Field Safety Notice for CARDIOHELP System by Maquet Cardiopulmonary AG PDF, 755KB, File does not meet accessibility standards Date: 18. March 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 04016/22

Urgent Field Safety Notice for Vessel Sealer Extend; SynchroSeal by Intuitive Surgical, Inc. PDF, 630KB, File does not meet accessibility standards Date: 18. March 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 05503/22

Urgent Field Safety Notice for Infinity Central Station CPU by Drägerwerk AG & Co. KGaA PDF, 166KB, File does not meet accessibility standards Date: 18. March 2022 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 05490/22

Urgent Field Safety Notice for Sentinex Pro/Smart Surgical gown by Lohmann und Rauscher GmbH & Co. KG PDF, 210KB, File does not meet accessibility standards Date: 16. March 2022 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 04568/22

Urgent Field Safety Notice for ExacTrac Dynamic by Brainlab AG PDF, 273KB, File does not meet accessibility standards Date: 16. March 2022 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Reference 04414/22

Urgent Field Safety Notice for Alinity m System by Abbott Molecular, Inc PDF, 482KB, File does not meet accessibility standards Date: 16. March 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 29538/21

Urgent Field Safety Notice for cobas z 480 analyzer by Roche Molecular Systems, Inc. PDF, 511KB, File does not meet accessibility standards Date: 16. March 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 20189/20

Urgent Field Safety Notice for EXALT Model D Single-Use Duodenoscope by Boston Scientific Corporation Marlborough PDF, 126KB, File does not meet accessibility standards Date: 16. March 2022 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - endoscopes
Reference 05275/22

Urgent Field Safety Notice for Vasofix Safety, Vasofix Certo by B. Braun Melsungen AG PDF, 241KB, File does not meet accessibility standards Date: 16. March 2022 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - syringes and cannulas
Reference 05385/22

Urgent Field Safety Notice for Randox Total Bile Acids by Randox Laboratories Ltd PDF, 3MB, File does not meet accessibility standards Date: 16. March 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 04972/22

Urgent Field Safety Notice for Pharmagel Breast pads, GEL7075 by Pharmaplast S.A.E. PDF, 4MB, File does not meet accessibility standards Date: 16. March 2022 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - others
Reference 05023/22

Urgent Field Safety Notice for V40 BIOLOX delta Ceramic Femoral Head by Stryker Orthopaedics-Mahwah PDF, 998KB, File does not meet accessibility standards Date: 16. March 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 01953/22

Urgent Field Safety Notice for Philips StentBoost Live used with Philips Allura a by Philips Medical Systems Nederland B.V. PDF, 2MB, File does not meet accessibility standards Date: 16. March 2022 Topics: Medical devices Type: Customer information

Product group Radiological technology - radiological equipment for vascular diagnostics
Reference 02773/22

Urgent Field Safety Notice for Trinity Acetabular Hip System by Corin Medical Ltd. PDF, 208KB, File does not meet accessibility standards Date: 16. March 2022 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 04328/22

Urgent Field Safety Notice for SonoFlex EBUS - Nitinol Nadel by Endo-Flex GmbH PDF, 102KB, File does not meet accessibility standards Date: 16. March 2022 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - endoscopes
Reference 04411/22

Urgent Field Safety Notice for cobas 8000 core unit, cobas pro sample supply unit, cobas c 513 analyzer commercial system by Hitachi High-Technologies Corporation PDF, 279KB, File does not meet accessibility standards Date: 16. March 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 20540/20

Urgent Field Safety Notice for Jobst Compri2 / Jobst Compri2 Lite by BSN medical GmbH PDF, 271KB, File does not meet accessibility standards Date: 16. March 2022 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology - orthoses
Reference 02261/22

Urgent Field Safety Notice for AGILON glenoid components by implantcast GmbH PDF, 1MB, File does not meet accessibility standards Date: 16. March 2022 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 00432/22

Urgent Field Safety Notice for UNIVERSAL TWINBAR 670 by Liko AB PDF, 221KB, File does not meet accessibility standards Date: 16. March 2022 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - ward equipment and equipment for emergency medical services
Reference 04287/22

Urgent Field Safety Notice for Alinity m System by Abbott Molecular, Inc PDF, 457KB, File does not meet accessibility standards Date: 16. March 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 03656/22

Urgent Field Safety Notice for NextSeq 550Dx by Illumina, Inc. PDF, 829KB, File does not meet accessibility standards Date: 16. March 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 04259/22

Urgent Field Safety Notice for Lithium_2 (LITH_2) reagents Enzymatic Hemoglobin A1c (A1c_E) reagents by Siemens Healthcare Diagnostics Inc. Tarrytown PDF, 669KB, File does not meet accessibility standards Date: 16. March 2022 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 03252/22