Summary of Field Safety Notices March 2025

16/04/2025
Medical devices Summary of field safety notices (FSN)

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

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

Documents

VasoView HemoPro 2 Endoscopic Vessel Harvesting (EVH) System_MAQUET Cardiovascular_Advice regarding the use of the device PDF : 1.18MB | 16/04/2025 Oracle Health Maternity_Cerner Corporation_Advice regarding a software update PDF : 801KB | 16/04/2025 Ringlight fiber & Ringlight Slim Fiber_LSO MEDICAL name_Advice regarding a device removal PDF : 215KB | 16/04/2025 Stimulation RC Clinician Programmer Application_Medtronic Inc_Advice regarding the use of the device PDF : 171KB | 16/04/2025 Perfusion Solutions_Carnamedica_IFU Update PDF : 300KB | 16/04/2025 NIM Vital Nerve Monitoring System_Medtronic Xomed_Advice regarding a software upgrade PDF : 200KB | 16/04/2025 Progressa_Hill-Rom (Baxter)_Advice regarding a device modification PDF : 177KB | 16/04/2025 My PTM App, Medtronic Inc., Advice regarding use of device PDF : 389KB | 16/04/2025 Giraffe Omnibed Carestation Giraffe Omnibed_Datex Ohmeda Inc_Advice regarding the use of the device_Attachment PDF : 327KB | 16/04/2025 FRED Easyport_Schiller_Advice regarding the use of the device PDF : 379KB | 16/04/2025 GS Corpuls defibrillation electrodes_Leonhard Lang GmbH_Advice regarding the use of the device PDF : 328KB | 16/04/2025 MIM Software_MIM Software Inc., GE HealthCare_Advice regarding the use of the device PDF : 142KB | 16/04/2025 Evolut PRO Plus, FX, FX Plus System_Medtronic CoreValve LLC_Advice regarding changes or updates made to instructions for use PDF : 156KB | 16/04/2025 Epoc BGEM Test Cards_EPOCAL_Advice regarding a software upgrade PDF : 269KB | 16/04/2025 Powerheart G5 AED_Zoll Medical Corporation_Advice regarding the use of the device PDF : 209KB | 16/04/2025 Various Centricity systems_GE Healthcare_Advice regarding a software upgrade PDF : 129KB | 16/04/2025 ID NOW COVID-19 2.0_Abbott Diagnostics Inc_Advice regarding a device removal PDF : 365KB | 16/04/2025 HALYARD PUREZERO Limon Nitrile Exam Gloves_OwensMinor_Advice regarding a device removal PDF : 214KB | 16/04/2025 Hugo RAS Sterile Interface Module_Covidien llc_Advice regarding a device removal PDF : 278KB | 16/04/2025 Endoflow II Irrigation and Warming System_Rocamed_Advice regarding changes made to instructions for use PDF : 251KB | 16/04/2025 Progressa_Hill-Rom (Baxter)_FSN Attachment A PDF : 109KB | 16/04/2025 DxI 9000 Access Immunoassay Analyzer_Beckman Coulter_Advice regarding the use of the device PDF : 129KB | 16/04/2025 Giraffe Omnibed Carestation Giraffe Omnibed_Datex Ohmeda Inc_Advice regarding the use of the device PDF : 79KB | 16/04/2025 CELL-DYN Ruby_Abbott Laboratories_Advice regarding the use of the device PDF : 143KB | 16/04/2025 3 Cell Screen_NHSBT_Advice regarding a device removal PDF : 63KB | 16/04/2025 Carestation 600 and 750 series_Datex Ohmeda Inc_Advice regarding use of the device PDF : 208KB | 16/04/2025 Amplatzer TorqVue LP Delivery System Catheter_Abbott Medical_Advice regarding a device removal PDF : 133KB | 16/04/2025 Access Vitamin B12 Reagent_Beckman Coulter, Inc._Advice regarding a device removal PDF : 178KB | 16/04/2025 ABL90 Flex and ABL90 Flex Plus Analyzer_Radiometer Medical ApS_Advice regarding the use of the device PDF : 119KB | 16/04/2025 Atellica CH Revised C-Reacticve Protein_Siemens Healthcare Diagnsotics Inc_Advice regarding the use of the device PDF : 331KB | 16/04/2025 da Vinci X Xi Grasping Retractor & Tenaculum Forceps_Intuitive Surgical_Advice regarding a device removal PDF : 239KB | 16/04/2025 CBC-5D_Bio-Techne_Advice regarding the use of a device PDF : 762KB | 16/04/2025