Summary of Field Safety Notices January 2025

12/02/2025
Medical devices Summary of field safety notices (FSN)

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

The naming convention for each document is <product name><manufacturer name><the nature of the FSN>. 

Documents

AK 95, AK 96, AK 98_Gambro Lundia AB_Advice regarding a device modification_HomepatientFSN PDF : 280KB | 05/02/2025 ETHILON™, PERMA-HAND™, PROLENE™ AND ETHIBOND EXCEL™ sutures_Ethicon LLC_Advice regarding a device removal PDF : 1.26MB | 04/02/2025 Heater-Cooler Unit HCU 40 HighLow Voltage_Maquet Cardiopulmonary GmbH_Advice regarding a device modification PDF : 357KB | 04/02/2025 da Vinci XXi Grasping Retractor & Tenaculum Forceps_Intuitive Surgican Inc_Advice regarding the use of the device PDF : 648KB | 04/02/2025 AK 95, AK 96, AK 98_Gambro Lundia AB_Advice regarding a device modification PDF : 372KB | 04/02/2025 Eclipse Pro and Eclipse Mini_Spacelabs Healthcare Ltd_Advice regarding the use of the device PDF : 298KB | 04/02/2025 Antimicrobial Susceptibility discs_Thermo Fisher Scientific_Advice regarding a device removal PDF : 266KB | 04/02/2025 Alinity m System, Alinity m HR HPV AMP Kit & Alinity m STI AMP Kit_Abbot Molecular Inc._Advice regarding the use of the device PDF : 51KB | 04/02/2025 Neilmed Nasogel Spray_Neilmed Pharmaceuticals Inc._Advice regarding a device removal PDF : 2.25MB | 04/02/2025 Sterile Container System, AESCULAP Aicon® Sterile Container System_Aesculap AG_Advice regarding a device modification PDF : 352KB | 04/02/2025 Venclose EVSRF Catheters_Venclose Inc._Advice regarding a device removal PDF : 266KB | 04/02/2025 Centricity PACS system_GE Healthcare_Advice regarding the use of the device_Original FSN PDF : 90KB | 04/02/2025 Carbomedics prosthetic heart valves_Corcym S.r.l._Advice regarding a device removal PDF : 151KB | 04/02/2025 da Vinci XXi Reusable Instrument Grip Cables_Inuitive Surgical Inc_Advice regarding the use of the device PDF : 684KB | 04/02/2025 Centricity PACS system_GE Healthcare_Advice regarding the use of the device_Follow up FSN PDF : 266KB | 04/02/2025 Olympus Guide Sheaths single use_Olympus Medical Systems Corporation_Advice regarding a device removal PDF : 236KB | 04/02/2025 Trilogy Evo, Trilogy Evo O2, Trilogy EV300_Philips Respironics_Advice regarding a software upgrade PDF : 398KB | 04/02/2025 Philips Allura and Azurion_Philips Medical Systems Nederland BV_Advice regarding the use of the device_FSN 2 PDF : 496KB | 04/02/2025 Optipac® Vacuum mixing system_Biomet France_Advice regarding the use of a device PDF : 309KB | 04/02/2025 Philips Allura and Azurion_Philips Medical Systems Nederland BV_Advice regarding the use of the device PDF : 562KB | 04/02/2025 PENTAX MEDICAL Video Processor EPK-i8020c and PENTAX Medical Video Endoscopes of the i20c series_HOYA Corp._Advice regarding changesupdates made to instructions for use DOCX : 89KB | 04/02/2025 Sedaconda Syringe_Sedana Medical_Advice regarding changes updates made to instructions for use PDF : 158KB | 04/02/2025 IRON 2_Roche Diagnostics GmbH_Advice regarding the use of the device PDF : 230KB | 04/02/2025 Model 1000 SenTiva™ and Model 1000-D SenTiva Duo™ VNS Therapy™ Generators_LivaNova USA Inc._Advice regarding the use of a device PDF : 149KB | 04/02/2025 Medima Infusion Pump_Medima So.zo.o._Advice regarding a software updgrade PDF : 312KB | 04/02/2025 Model 1000 SenTiva™ and Model 1000-D SenTiva Duo™ VNS Therapy™ Generators_LivaNova USA Inc._Advice regarding the use of a device_FSN 2 PDF : 303KB | 04/02/2025 Leica CM1950_Leica Biosystems Nussloch GmbH_Advice regarding the use of the device PDF : 417KB | 04/02/2025 Multiva 1.5T, Multiva 1.5T 16 R5, Multiva 1.5T 8 R5_Philips Healthcare (Suzhou) Co., Ltd_Advice regarding a device modification PDF : 374KB | 04/02/2025 Activa SC pocket adaptor for deep brain stimulation_Medtronic_Advice regarding a software upgrade PDF : 137KB | 04/02/2025