Summary of Field Safety Notices September 2025

06/10/2025
Medical devices Summary of field safety notices (FSN)

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

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

Documents

Nipro Corporation_Surdial X_Advice regarding device modification_Follow Up PDF : 1.08MB | 06/10/2025 SenTiva Model 1000_1000-D VNS Therapy Generators_LivaNova_Advice regarding a device removal DOCX : 121KB | 06/10/2025 VIDAS HIV DUO AG AB_bioMérieux SA_Advice regarding the use of the device PDF : 352KB | 06/10/2025 TactiFlex Ablation Catheter Sensor Enabled_Abbott_Advice regarding changes updates made to instructions for use PDF : 304KB | 06/10/2025 STA Liatest DDi Plus_Diagnostica Stago_Advice regarding Lot Removal PDF : 250KB | 06/10/2025 RENZAN™ Peripheral Stent System_MicroVention Europe SARL_Advice regarding a device removal PDF : 125KB | 06/10/2025 Olympus Bronchofiberscopes and Bronchovideoscopes_Olympus Medical Systems Corporation_Advice regarding updates made to instructions for use PDF : 305KB | 06/10/2025 Mako Total Knee_Stryker Joint Replacement_Advice regarding a software upgrade PDF : 241KB | 06/10/2025 MADSEN AccuScreen TEAOE DPOAE ABR Probe_Advice regarding the use of the device PDF : 296KB | 06/10/2025 Incisive CT_CT 5300_Philips_advice regarding a software upgrade PDF : 564KB | 06/10/2025 MAJ-103 Tubing 2M (Pack of 5)_Olympus KeyMed_Advice regarding a device removal PDF : 414KB | 06/10/2025 InterSurgical Ltd._i-view Video Laryngoscope-Advice regarding device removal PDF : 201KB | 06/10/2025 Dexcom_Dexcom G6 OUS iOS CGM App_Adcie regardign software upgrade PDF : 531KB | 06/10/2025 GORE® ACUSEAL Vascular Graft_W.L.Gore& Associates, Inc. Medical Product Division_Advice regarding updates made PDF : 214KB | 06/10/2025 DxI 9000 Access Immunoassay Analyzer_Beckman Coulter_Advice Regarding the Use of the Device PDF : 192KB | 06/10/2025 Heyex 2_Heyex PACS Ashvins Variant_Medical Communications GmbH_advice regarding a software upgrade PDF : 206KB | 06/10/2025 ACCOLADE Pacemakers and CRT-Ps_Cardiac Pacemaker Inc Boston Scientific Corporation_Advice regarding a software upgrade PDF : 421KB | 06/10/2025 AXTAIR_Winncare_Advice regarding the use of the device PDF : 254KB | 06/10/2025 Automated Impella Controller_Abiomed_advice regarding a device modification PDF : 322KB | 06/10/2025 CODMAN Disposable Perforator 9mm and 11mm_Integra LifeSciences Production Corporation_Advice regarding a device removal PDF : 321KB | 06/10/2025 Baxter Healthcare_Sahresource Claria_Advice regarding software upgrade PDF : 291KB | 06/10/2025 Baxter Healthcare SA-EVO IQ Large Volume Pump-Advice regarding software upgrade_Follow up PDF : 207KB | 06/10/2025 Catalyft PL Expandable Interbody System_Medtronic Sofamor Danek USA, Inc._Advice regarding the use of the device PDF : 194KB | 06/10/2025 Getinge Disinfection AB_Getinge 88-series_Advice regarding device modification PDF : 317KB | 06/10/2025 Allura Xper_Allura Centron_Allura CV20_Philips_advice regarding a device modification PDF : 243KB | 06/10/2025 Alcon Laboratories Inc._ULTRAVIT & HYPERVIT Vitrectomy Probe_Advice Regarding the Use of the Device PDF : 180KB | 06/10/2025 Allura Xper_Allura CV20_Philips_advice regarding a device modification PDF : 401KB | 06/10/2025 AIRVO2 Humidifier myAIRVO2 Humidifier_Fisher &Paykel healthcare limited_Advice reagarding changes updates made to instructions for use PDF : 138KB | 06/10/2025 ADSON-BROWN TISSUE FORCEPS 12CM_Tekno-Medical Optik-Chirurgie GmbH_Advice regarding a device removal PDF : 166KB | 06/10/2025