Summary of Field Safety Notices August 2025

01/09/2025
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

Sterowipe Non-sterile Alcohol Free Skin Cleansing Wipes_Steroplast Healthcare Limited_Advice Regarding Device Removal PDF : 2.59MB | 01/09/2025 Op-Air One FEELDRY – TIIR_Medicom SAS_Advice regarding a device removal PDF : 3.9MB | 01/09/2025 Microsafe Alcohol Free Cleansing Wipe (Non-Sterile)_Naturelle Consumer Products Ltd_Advice Regarding Device Removal PDF : 787KB | 01/09/2025 Philips Allura and Azurion_Philips_Advice regarding a device modification PDF : 461KB | 01/09/2025 3T MRI Systems_Siemens Healthcare GmbH_Advice regarding the use of the device PDF : 368KB | 01/09/2025 ViziShot 2 FLEX (19G)_Olympus Surgical Technologies America_Advice regarding a device removal PDF : 444KB | 01/09/2025 Thermax Blood Warmer Unit Prismax V3 Prismax V2_Baxter Healthcare SA_Advice regarding use of device PDF : 244KB | 01/09/2025 tslim X2 Insulin Pump_Tandem Diabetes Care_Advice regarding use of device and device replacement PDF : 173KB | 01/09/2025 Triage® Troponin I Test_QuidelOrtho Corporation_Advice regarding a lot removal PDF : 241KB | 01/09/2025 Surdial X_Nipro Corporation_Advice regarding device modifiation PDF : 115KB | 01/09/2025 StrykeFlow 2 Suction Irrigator_Stryker Endoscopy_Advice regarding a device removal PDF : 355KB | 01/09/2025 HistoCore PELORIS 3_Leica Biosystems Melbourne Pty Ltd_Advice regarding the use of the device PDF : 768KB | 01/09/2025 Medihoney_Derma Sciences Inc._Advice Regarding a Device Removal PDF : 290KB | 01/09/2025 HistoPot 5L_Serosep Ltd_Advice regarding a device removal PDF : 373KB | 01/09/2025 SpeedControl Dial utilized with SmartDrive MX2 Power Assist Device_Max Mobility_Advice regarding a device removal PDF : 182KB | 01/09/2025 Vasoview Hemopro 2_MAQUET Cardiovascular LLC-Getinge_Advice regarding updates made to instructions for use_Follow Up FSN PDF : 195KB | 01/09/2025 Getinge 88-series_Getinge Disinfection AB_Advice Regarding Device Modification PDF : 317KB | 01/09/2025 Defibrillation electrodes F7987W_FIAB_Advice regarding a device removal PDF : 385KB | 01/09/2025 corpuls, corpuls3 touch_GS Elektromedizinische Geräte G. Stemple GmbH_ Advice regarding updates made to instructions for use PDF : 339KB | 01/09/2025 Enterprise Archive_GE Healthcare_Advice regarding the use of the device PDF : 114KB | 01/09/2025 Atellica CH Urinary Cerebrospinal Fluid Protein Assay_Siemens Healthcare Diagnsotics Inc_Advice regarding the use of the device PDF : 614KB | 01/09/2025 CADD Medication Casette Reservoir_ICU Medical_Advice regarding a device removal PDF : 291KB | 01/09/2025 Elefant® Suction-Irrigation device_Coloplast AS_Advice regarding a device removal PDF : 218KB | 01/09/2025 Atellica CH Urinary Cerebrospinal Fluid Protein Assay_Siemens Healthcare Diagnsotics Inc_Updated FSN PDF : 461KB | 01/09/2025 DLP Left Heart Vent Catheters_Medtronic Inc._Advice regarding device removal PDF : 191KB | 01/09/2025 ARGUS PB-3000_Schiller AG_Advice regarding a device modification PDF : 369KB | 01/09/2025 Alcon Standalone Vitrectomy Consumables_Alcon Laboratories, Inc._Advice Regarding Device Removal PDF : 279KB | 01/09/2025 ARGUS PB-3000_Schiller AG_service note PDF : 316KB | 01/09/2025 Brilliance, Ingenuity, IQon Spectral CT_Philips Medical Systems Nederland B.V._Advice regarding the use of the device PDF : 262KB | 01/09/2025