Summary of Field Safety Notices July 2025

13/08/2025
Medical devices Summary of field safety notices (FSN)

We have published a monthly summary of Field Safety Notices (FSN) affecting the Irish market for July 2025 below. 

The naming convention for each document is <product name><manufacturer name><type of action taken by manufacturer.

Documents

Access hsTnI Reagent Kit_Immunotech S.A.S_Advice regarding changes updates made to instructions for use PDF : 168KB | 13/08/2025 VentStar Helix_ Dragerwerk_Advice regarding device removal PDF : 996KB | 13/08/2025 SureTek Burr Hole Cover Kit_Boston Scientific Neuromodulation Corporation_Advice regarding updates made to instructions for use PDF : 338KB | 13/08/2025 Philips MR Systems_Philips Medical Systems Nederland B.V._Advice regarding a software upgrade PDF : 587KB | 13/08/2025 WATCHMAN TruSeal™ Access System, WATCHMAN FXD Curve™ Access System_Boston Scientific Corporation_Advice regarding updates made to instructions for use PDF : 243KB | 13/08/2025 Vercise Genus Implantable Pulse Generator System_Boston Scientific Neuromodulation Corporation_Advice regarding updates made to instructions for use PDF : 296KB | 13/08/2025 2 cell screen CS_NHSBT_Advice regarding a device removal PDF : 63KB | 13/08/2025 Various GE Healthcare MR systems_GE Medical Systems_Advice regarding the use of the device PDF : 165KB | 13/08/2025 Endotak Reliance ePTFE (GORE) defibrillation leads_Cardiac Pacemaker Inc. (Boston Scientific)_Advice regarding the use of the device PDF : 929KB | 13/08/2025 Epoc BGEM Test Cards_Siemens Healthcare Diagsnotics Inc_Advice regarding the use of the device PDF : 264KB | 13/08/2025 Hugo RAS Sterile Interface Module_Covidien llc_Advice regarding a device removal_Follow Up FSN PDF : 154KB | 13/08/2025 HemosIL Heparin Calibrators_Instrumentation Laboratory Co._Advice regarding the use of the device PDF : 164KB | 13/08/2025 Multiple GE Healthcare nuclear medicine systems_GE Medical Systems_Advice regarding the use of the device_Follow up FSN PDF : 816KB | 13/08/2025 Multiple GE Healthcare nuclear medicine systems_GE Medical Systems_Follow up FSN cover letter PDF : 266KB | 13/08/2025 Multiva 1.5T_Philips Healthcare (Suzhou) Co., Ltd_Advice regarding a software upgrade PDF : 566KB | 13/08/2025 Philips Allura System_Philips Medical Systems_Advice regarding a software upgrade PDF : 450KB | 13/08/2025 Infinia and VG Series nuclear medicine systems_GE Medical Systems_Advice regarding a device modification PDF : 170KB | 13/08/2025 Ringlight fiber & Ringlight Slim Fiber_LSO MEDICAL name_Advice regarding a device removal_Follow Up FSN PDF : 267KB | 13/08/2025 Fortress Introducer Sheath System, 6F Straight 45c_Contract Medical International GmbH_Advice regarding the use of the device PDF : 398KB | 13/08/2025 Encore 26 Inflation Device_Boston Scientific Corporation name_Advice regarding a device removal PDF : 394KB | 13/08/2025 Atellica CH Revised C-Reactive Protein_Siemens Healthcare Diagnostics Inc_Follow-Up FSN PDF : 256KB | 13/08/2025 da Vinci X and Xi Systems_Intuitive Surgical_Advice regarding the use of the device_Follow Up FSN PDF : 1.19MB | 13/08/2025 CareLink SmartSync_Medtronic Inc_Advice regarding a software upgrade PDF : 285KB | 13/08/2025 Dexcom One Dexcom G7 Dexcom One plus receivers_Dexcom Inc_Advice regarding use of device PDF : 225KB | 13/08/2025 Ambu Spur II_Ambu AS_Advice regarding device removal PDF : 456KB | 13/08/2025 Electrosurgical Generator - ESG-410_Olympus Winter & Ibe GmbH_Advice regarding a device modification PDF : 253KB | 13/08/2025 Dexcom One plus_Dexcom Inc_Advice regarding software update PDF : 565KB | 13/08/2025 CORIN Operating table_MAQUET GmbH_Advice regarding a software upgrade PDF : 189KB | 13/08/2025 Easymoov6_Medwin_Advice regarding use of device PDF : 370KB | 13/08/2025 Dragonfly and Phantom_Metrex Research LLC dba Orascoptic_Advice Regarding Device Modification PDF : 90KB | 13/08/2025 Dexcom G7 G7 Watch_Dexcom Inc_Advice regarding software update PDF : 565KB | 13/08/2025 Acurate neo2 and Prime Aortic Valve System_Boston Scientific Corporation_Advice regarding a device removal_Follow Up FSN PDF : 276KB | 13/08/2025 Carotid WALLSTENT™ Monorail Endoprosthesis_Boston Scientific_Advice regarding a device removal PDF : 327KB | 13/08/2025 Automated Impella Controller_Abiomed Inc_Advice regarding the use of the device PDF : 279KB | 13/08/2025 BIOFIRE FILMARRAY TORCH Base_BioFire Diagnostics, LLC_Advice regarding the use of the device PDF : 302KB | 13/08/2025