Summary of Field Safety Notices November 2025

08/12/2025
Medical devices Summary of field safety notices (FSN)

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

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

Documents

BD BACTEC™ MGIT™ 960 PZA Kit_Becton Dickinson and Company_Advice regarding changesupdates to IFU PDF : 303KB | 04/11/2025 Bicarbonate_Beckman Coulter_Updated FSN_Advice regarding the use of the device PDF : 261KB | 17/11/2025 Carelink Clinic_Medtronic_advice regarding software update PDF : 151KB | 31/10/2025 CamAPS and mylife CamAPS_Cam Diab Ltd._Advice regarding update to instructions for use_end users_Healthcare professionals PDF : 168KB | 28/10/2025 Cardiosave Intra-Aortic Balloon Pumps_Datascope Corporation Getinge_Advice regarding updates made to instructions for use PDF : 206KB | 31/10/2025 Clark defibrillator_Lifeaz SAS_Advice regarding a software update PDF : 148KB | 31/10/2025 Elecsys Anti-TSHR_Roche Diagnostics GmbH_Advice regarding the use of the device PDF : 132KB | 30/11/2025 Clearway 2_Breas Medical Ltd._Advice regarding software update and device modification PDF : 191KB | 28/10/2025 Elekta Synergy, Elekta Infinity, Elekta Harmony, Elekta Harmony Pro, Versa HD, Elekta Evo (EMLA)_Elekta Solutions AB_Advice regarding the use of the device PDF : 186KB | 30/11/2025 DEFIGARD Touch-7_Schiller_Advice regarding a software update PDF : 236KB | 30/11/2025 Hand Files_Kerr Italia S.r.l_Advice regarding changes or updates made to instructions for use PDF : 245KB | 07/11/2025 HemosIL SynthAFax_Instrumentation Laboratory)Advice regarding device removal PDF : 248KB | 24/11/2025 Color Coded Syringe_MedNet GmbH_Advice regarding device removal PDF : 307KB | 07/11/2025 Intracranial Pressure Monitor Pressio®2_SOPHYSA_Advice regarding a software upgrade PDF : 308KB | 17/11/2025 IntelliVue Patient Monitor_Philips Medizin Systeme Böblingen GmbH_Advice regarding the use of the device PDF : 445KB | 31/10/2025 Giraffe Omnibed Carestation CS1; Giraffe Omnibed_Datex-Ohmeda, Inc_Advice regarding the use of the device PDF : 478KB | 30/10/2025 Inlay Optima Ureteral Stents_C.R. Bard, Inc._Advice regarding a device removal PDF : 382KB | 06/11/2025 MedNet Syringes in Arc Royal Procedure packs_Arc Royal uc an Owens & Minor Company_Advice regarding device removal PDF : 193KB | 18/11/2025 NICO Myriad System, Illumination Pack, BrainPath_NICO CORP_Advice regarding the use of the device PDF : 674KB | 30/11/2025 OTESUS OR table column_Maquet Getinge_Customer Response Form DOCX : 45KB | 30/11/2025 Celox PPH Uterine Haemostatic Tamponade_Medtrade Products Ltd_Advice regarding updates made to IFU PDF : 2.84MB | 29/10/2025 NOxBOXi_ NOxBOX ltd_Advice regarding software update PDF : 332KB | 30/11/2025 Q-link 13_Liko AB_Advice regarding a device removal PDF : 177KB | 07/11/2025 OTESUS OR table column_Maquet Getinge_Advice regarding a device modification PDF : 216KB | 30/11/2025 Ortho Vision and Vison Max Analysers and ORTHO Sera Anti-N_QuidelOrtho_Advice regarding the use fo the device PDF : 123KB | 13/11/2025 Red and Blue syringes supplied with Medline surgical kits_Medline International France _Advice regarding device removal PDF : 396KB | 25/11/2025 Restore™ Clinician Programmer Application_Medtronic, Inc._Advice regarding a software upgrade PDF : 106KB | 30/11/2025 Maxima Diamond Burs_Henry Schein Inc._Advice regarding updates made to IFU PDF : 2.65MB | 30/11/2025 Single Use Litigating Device Polyloop_ Olympus Europa SE & Co_Advice regarding the use of the device PDF : 712KB | 07/11/2025 Various Ultrasound Systems_BK Medical Aps_GE Healthcare_Advice regarding changes made to IFU PDF : 255KB | 08/12/2025 Ultramat S_SDI Limited_Advice regarding device modification PDF : 383KB | 31/10/2025 ViewPoint 6_GE Healthcare GmbH_Advice regarding a software update PDF : 85KB | 08/12/2025 Various patient monitors_GE_Advice regarding a device modification PDF : 424KB | 08/12/2025 SunStim, SunStim Plus, SunStim Pro_EasyMed Instruments Co., Ltd._Advice regarding a device removal PDF : 168KB | 11/11/2025 Xpert CT NG (reagent)_Cepheid AB_Advice regarding the use of the device PDF : 358KB | 16/10/2025 basixCompak Inflation Device_Merit Medical Inc_Advice regarding the use of the device PDF : 269KB | 08/12/2025 Rocket Seldinger Chest Drain Kit_Rocket Medical_Advice regarding updates made to instructions for use PDF : 1.23MB | 16/10/2025 ZenFlex Rotary File_Kerr Italia S.r.l_Advice regarding changes or updates made to instructions for use PDF : 149KB | 06/11/2025