Summary of Field Safety Notices April 2025

19/05/2025
Medical devices Summary of field safety notices (FSN)

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

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

Documents

GOT Multi_ALCHIMIA_Update to the Labelling PDF : 3.58MB | 19/05/2025 Aqualine, Aqualine S, Aqualine RCA, Aqualine D_Haemotronic SpA_Advice regarding use of a device_Follow up FSN PDF : 1.18MB | 19/05/2025 CODMAN Disposable Perforator 14mm_Integra LifeSciences Production Corporation_Advice regarding a device removal PDF : 325KB | 19/05/2025 Centricity High Acuity Anesthesia Critical Care_GE Healthcare_Advice regarding use of the device PDF : 228KB | 19/05/2025 CABG Pack containing Electrosurgical Pencil_ArcRoyal uc_Advice regarding the use of the device PDF : 266KB | 19/05/2025 Check-Flo Performer Introducer_Cook Incorporated_Advice regarding a device removal PDF : 171KB | 19/05/2025 Blueprint Mixed Reality System_Tornier SAS_Advice regarding a device removal PDF : 363KB | 19/05/2025 Alinity m System_Abbott Molecular Inc._Advice regarding the use of the device PDF : 137KB | 19/05/2025 Bard Minnesota Four-Lumen Esophagogastric Tamponadade Tube_C.R. Bard, Inc._Product removal PDF : 293KB | 19/05/2025 Anaesthesia system_GE Healthcare_Advise regarding device modification PDF : 137KB | 19/05/2025 Welch Allyn Connex Vital Signs Monitor (CVSM), CP150 Electrocardiograph & Connex Spot Monitor Accessory Power Management Stand (APM)_WelchAllyn Inc_Advice regarding the use of the device PDF : 466KB | 19/05/2025 4Fr Single Lumen PowerPICC_Bard Access Systems_ Product Removal _Follow Up FSN PDF : 393KB | 19/05/2025 BCID2 Panel_BioFire Diagnostics, LLC_Advice regarding a software ugrade PDF : 267KB | 19/05/2025 DORO Easy-Connect Navigation Adaptor BRAINLAB_pro med instruments GmbH_Advice regarding a device removal PDF : 2.2MB | 19/05/2025 Ascenda Intrathecal Catheter and Ascenda Intrathecal Cather Pump Segment Revision Kit-Medtronic Inc._Advice regarding device removal_Follow up FSN PDF : 140KB | 19/05/2025 Venue Go_Venue Fit Ultrasound Systems_GE Healthcare_advice regarding a device modification and software upgrade PDF : 689KB | 19/05/2025 BiPAP A30_BiPAP A40_Philips_advice regarding the use of the device_Follow up FSN PDF : 540KB | 19/05/2025 Tempus Pro Monitor_Philips_advice regarding a software upgrade PDF : 995KB | 19/05/2025 TufTex Over-the-Wire Embolectomy Catheter, Pruitt Occlusion Catheter, Pruitt Irrigation Occlusion Catheter_LeMaitre Vascular, Inc._Advice regarding a device removal PDF : 397KB | 19/05/2025 Patient Monitoring Devices and Wall Systems; Manual Blood Pressure Gauges and Cuffs_Welch Allyn Inc_Advice regarding a device removal PDF : 804KB | 19/05/2025 Tempus Pro Monitor_Philips_advice regarding updates made to instructions for use PDF : 621KB | 19/05/2025 IntelliSpace Cardiovascular 6.x, 7.x, and 8.x_Philips_advice regarding a software upgrade PDF : 576KB | 19/05/2025 Creatinine_Beckman Coulter Inc._Advice regarding a device removal PDF : 186KB | 19/05/2025 Rocket Thoracentesis Catheter_Rocket Medical Plc_Device Removal PDF : 228KB | 19/05/2025 Microstream Advance Intubated CO2_Phillips_IFU update PDF : 382KB | 19/05/2025 Soltive Laser System_Gyrus ACMI, Inc._Advice regarding a software upgrade PDF : 258KB | 19/05/2025 Sinus-SuperFlex-DS_optimed Medizinische Instrumente GmbH_Advice regarding the use of the device PDF : 241KB | 19/05/2025 Tornado Embolization Microcoil_Cook Incorporated__Advice regarding a device removal PDF : 173KB | 19/05/2025 Free Go Pump._Zevex Inc.(doing business as Moog Medical devices)_Advice regarding software update_Follow up FSN PDF : 598KB | 19/05/2025 HEMAPATCH WOVEN_Intervascular SAS_IFU Update PDF : 381KB | 19/05/2025 MicroSlide Introducer Kit_Galt Medical Corp._Advice regarding a device removal PDF : 214KB | 19/05/2025 Glooko Web Application-Glooko Inc._Advice Regarding IFU Update PDF : 138KB | 19/05/2025 EyeWick_GRI Medical & Electronic Technology Co., Ltd._Advice regarding a device removal PDF : 84KB | 19/05/2025 Collagen Plugs and OPAQUE Herrick Lacrimal Plugs_Lacrimedics Inc_Advice regarding a device removal PDF : 247KB | 19/05/2025 Dexcom G6 Receiver_Dexcom_Advise regarding software update PDF : 84KB | 19/05/2025