Summary of Field Safety Notices October 2025

20/11/2025
Medical devices Summary of field safety notices (FSN)

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

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

Documents

Vyntus devices with SNIP option_Jaeger_Advise on reprocessing instructions PDF : 342KB | 18/08/2025 rr Antibody Screen_NHSBT_Advise on lot removal PDF : 107KB | 23/09/2025 VITUS-Fi Distal Fibula Nail_Dieter Marquardt Medizintechnik_Advise regarding a device removal PDF : 353KB | 26/09/2025 ShockPulse Lithotripsy Transducer & ShockPulse-SE Lithotripsy System_Gyrus ACMI, Inc (Olympus Surgical Technologies America)_Advice regarding the use of the device PDF : 234KB | 31/10/2025 BDAlarisSyringePumps_BDSwitzerland_Advice regarding device modification PDF : 371KB | 08/10/2025 CARESCAPE Central Station_GE Medical Systems Information Technologies, Inc._Advice regarding a software upgrade PDF : 157KB | 07/10/2025 SnareMaster Plus HotCold_Olympus Medical Systems Corporation_Advice regarding a product removal PDF : 829KB | 31/10/2025 HeartSine samaritan Pad-Pak and Pediatric-Pak_Heartsine Technologies Ltd._Advice regarding the use of the device PDF : 558KB | 06/10/2025 Eterna SCS IPG_Abbott Medical_Advice regarding the use of the device PDF : 205KB | 31/10/2025 Philips Azurion System_Philips Medical Systems Nederland BV_Advice regarding the use of the device PDF : 705KB | 01/10/2025 Certain Nuclear Medicine Systems_GE medical Systems Israel, Functional Imaging_Advice regarding the use of the device PDF : 130KB | 31/10/2025 AW Server_GE Medical Systems SCS_Advice regarding the use of the device PDF : 168KB | 10/10/2025 NextSeq 550Dx Flow Cell_Illumina Inc_Advice regarding Device removal PDF : 309KB | 28/10/2025 Kendall SCD™ 700 Sequential Compression System_Cardinal Health_Advice regarding the use of the device PDF : 248KB | 22/10/2025 Bicarbonate_Beckman Coulter_Advice regarding the use of the device PDF : 322KB | 07/10/2025 Aurora EV-ICD™ MRI SureScan™_Medtronic Inc._Advice regarding a software upgrade PDF : 317KB | 31/10/2025 EASY PULSE_SCHILLER AG_Advice regarding a software upgrade PDF : 358KB | 17/10/2025 Olympus Duodenovideoscopes_Olympus Medical Systems Corporation_Advice regarding the use of the device PDF : 410KB | 17/10/2025 Automated Digital Cell Morphology Analyser DI-60_Cellavision_Advice regarding firmware update PDF : 384KB | 10/10/2025 HeartMate II and HeartMate3 System Controllers_Abbott Medical_Advice regarding the use of the device PDF : 457KB | 31/10/2025 Clear Therm Mini Paediatric HMEF_Intersurgical_Advice regarding the use of device PDF : 830KB | 17/10/2025 Multiva 1.5T MR System_Philips Healthcare (Suzhou) Co., Ltd_Advice regarding the use of the device PDF : 325KB | 21/10/2025 MAC VU360_GE Medical Systems Information Technologies, Inc._Advice regarding the use of the device PDF : 99KB | 31/10/2025 AK98_Gambro Lundia AB_Advice regarding the use of device_Follow up PDF : 302KB | 22/10/2025 AK98_Gambro Lundia AB_Advice regarding use of a device_Followup_home patients letter PDF : 231KB | 22/10/2025 Automated Impella Controller (AIC)_Abiomed Inc._Advice regarding a software upgrade PDF : 284KB | 10/10/2025 Sectra Core_Sectra AB_Advice regarding a software upgrade PDF : 1.37MB | 14/10/2025 9180 Electrolyte Analyzer_Roche Diagnostics_Advice regarding the use of the device PDF : 36KB | 27/10/2025 FreeGo Enteral Feeding Set_Abbott Ireland_Advice regarding use of a device PDF : 2.9MB | 06/10/2025 CitraLock S 4% (EN)_rev02_Steriset manufactring S. A_advise regarding device removal PDF : 257KB | 13/10/2025 Autocal_Human Gesellschaft fur Biochemica und Diagnostica mbH_Advice Regarding the Use of the Device PDF : 207KB | 16/10/2025 MiniCap Extended Life PD transfer_Baxter_Advise regarding replacement of device PDF : 390KB | 24/10/2025 NovoTHOR and NovoTHOR XL_THOR Photomedicine Ltd._Advice regarding a device modification PDF : 441KB | 23/10/2025 BiPAP A40 Pro_Phillips Respironics_Advise regarding removal PDF : 372KB | 26/06/2025 Salem Sump_Cardinal health_Advise on instructions for device use PDF : 176KB | 07/10/2025 CentriMag Blood Pump_Abbott Medical_Advice regarding use of device PDF : 229KB | 31/10/2025 Introducer Kit for Gastrostomy Feeding Tubes_Avanos_advise regarding use of the device PDF : 2.65MB | 18/06/2025 Dart Intranasal Mucosal Atomisation Device_Pulmodyne_Advice regarding device removal PDF : 253KB | 24/10/2025