Summary of Field Safety Notices June 2025

04/07/2025
Medical devices Summary of field safety notices (FSN)

We have published a monthly summary of Field Safety Notices (FSN) affecting the Irish market for May2025 below. 

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

Documents

Philips Visions PV.014P, PV.014P RX, and PV.018 Digital IVUS Catheter_Philips_Advice regarding updates made to instructions for use PDF : 940KB | 04/07/2025 Venclose EVSRF Catheters_Venclose, Inc._Advice regarding a device removal_Follow Up FSN PDF : 231KB | 04/07/2025 THERAKOS CELLEX Photopheresis Procedural kit_Mallinckrodt Pharmaceuticals_Advice on device removal PDF : 471KB | 04/07/2025 Laserguard Silicone Ocular Shields_Medasil Surgical Limited (UK)_Advice regarding updates made to instructions for use PDF : 2.52MB | 04/07/2025 Sprinter Cart_Maquet Cardiopulmonary_Advise regarding device modification PDF : 425KB | 04/07/2025 Philips MRI Systems_Philips Medical Systems Nederland B.V._Advice regarding the use of the device PDF : 427KB | 04/07/2025 Q-Link 13_Liko AB_Advice regarding the use of the device PDF : 174KB | 04/07/2025 Philips Spectral CT_Philips_Advice regarding a software update PDF : 417KB | 04/07/2025 SafeStar Plus Twinstar HEPA Plus_Dragerwerk AG & Co. KGaA_Advice regarding updates made to IFU PDF : 208KB | 04/07/2025 One piece Guedel Airway_Intersurgical_Adivce regarding device removal PDF : 313KB | 04/07/2025 Philips Azurion Systems_Philips_Advice regarding a software update PDF : 303KB | 04/07/2025 LIFEPEARL™ Drug Elutable Microspheres_MicroVention Europe SARL_Advice regarding a device removal PDF : 254KB | 04/07/2025 Invacare Robin hoist_Invacare_Periodic Inspection Checklist PDF : 1.14MB | 04/07/2025 Invacare Robin hoist_Invacare_Advice regarding updates made to instructions for use PDF : 194KB | 04/07/2025 Newport™ HT70 and Newport™ HT70 Plus Ventilators_Medtronic_Advise regarding recall for specific serial numbers PDF : 171KB | 04/07/2025 Invacare Birdie lifter_Invacare_Safety inspection Checklist PDF : 707KB | 04/07/2025 Instrument Arm Drape SP_Intuitive Surgical, Inc._Advice regarding the use of the device PDF : 451KB | 04/07/2025 OptiSite Arterial Cannula, Femoral Arterial Cannul_ Edwards Lifesciences LLC_Advise regaring device recall-removal PDF : 187KB | 04/07/2025 Nellcor Bedside SpO2 Patient Monitoring System_Covidien llc_Advice regarding the use of the device PDF : 270KB | 04/07/2025 mo-vis R-net joysticks_mo-vis_Advice regarding a device modification PDF : 584KB | 04/07/2025 Invacare Birdie lifter_Invacare_Advice regarding updates made to instructions for use PDF : 217KB | 04/07/2025 iD-Paddle Internal Defibrillation Paddle Large_Smart Clinical Products bv_Advice regarding a device removal PDF : 290KB | 04/07/2025 Instrument Arm Drape SP_Intuitive Surgical, Inc._ Advice regarding a device removal_Follow Up FSN PDF : 181KB | 04/07/2025 Inpen App_ Medtronic minimed_Advice on software update PDF : 192KB | 04/07/2025 Hugo™ RAS Surgeon Console_ Covidien llc_Advice regarding the use of the device PDF : 176KB | 04/07/2025 CORFLO Nasogastric Nasointestinal Feeding Tube with Stylet with ENFit Connector_Avanos_advise regarding update to IFU PDF : 2.96MB | 04/07/2025 HeartSine Samaritan PAD SAM 350P SAM 360P SAM 450P SAM 500 P_HeartSineTechnologies Ltd_Advice regarding a device removal PDF : 292KB | 04/07/2025 Dexcom One _Dexcom_Advice on software update PDF : 91KB | 04/07/2025 Dexcom G7 iOS CGM App_Dexcom Inc_Advice regarding software update PDF : 140KB | 04/07/2025 Cook Beacon® Tip 5.0 Fr Angiographic Catheter_Cook Incorporated_Advice regarding a device removal PDF : 248KB | 04/07/2025 Caphosol_Recordati Netherlands B.V._Advice regarding a device removal PDF : 592KB | 04/07/2025 BVM Resuscitators_intersurgical_Advise regarding device removal PDF : 326KB | 04/07/2025 Allon_Belmount Medical Technologies_Advice regarding use of device and software update PDF : 342KB | 04/07/2025 CareLink SmartSync_Medtronic Inc_Advice regarding a software update PDF : 272KB | 04/07/2025 Change Healthcare Cardiology_Change Healthcare_Advice regarding a software update PDF : 173KB | 04/07/2025 BD FACS 7-Colour Setup Beads_Becton, Dickinson and Company_Advice regarding the use of the device PDF : 631KB | 04/07/2025 Alcian BluePASHematoxylin Stain Kit_Agilent Technologies_Advice regarding a device removal PDF : 192KB | 04/07/2025 ADVIA SETpoint Calibrator & ADVIA TESTpoint Control_Siemens Healthcare Diagnostics Inc_Advice regarding the use of the device PDF : 216KB | 04/07/2025 3M Ranger Blood Fluid Warming System 3M Ranger Irrigation Fluid Warming System_3M Comapny_Advice regarding updates to IFU PDF : 444KB | 04/07/2025 3mensio Workstation_Pie Medical Imaging_Advice regarding a software update PDF : 456KB | 04/07/2025