Summary of Field Safety Notices May 2026

08/06/2026
Medical devices Summary of field safety notices (FSN)

We have published a monthly summary of Field Safety Notices (FSN) affecting the Irish market for May 2026 below. 

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

Documents

MR Systems with SW versions R11.1 and R12.1_Philips Medical Systems_Advice regarding a software update_Updated FSN PDF : 527KB | 08/06/2026 Oncomine Dx Express Test Panel_ThermoFisher_advice regarding review of patient results PDF : 282KB | 08/06/2026 Oxoid Agglutinating Sera, Salmonella 9-0_ThermoFisher_Advice regarding Device Removal PDF : 395KB | 08/06/2026 NAVIFY Digital Pathology_Ventana Medical Systems Inc._Advice Regarding a Software Upgrade PDF : 425KB | 08/06/2026 Merlin 3650 Patient Care System Software Model 3330_Abbott_Advice regarding a software upgrade PDF : 174KB | 08/06/2026 Medline Namic White Star Handle Manifold_Kimal PLC_Advice regarding a device removal PDF : 321KB | 08/06/2026 Medline Namic White Star Handle Manifold Updated FSN_Medline Industries_Advice regarding a device removal PDF : 502KB | 08/06/2026 Histopot 5L Jerry Can_Serosep Limited_Advice regarding the use of a device PDF : 692KB | 08/06/2026 Gelli-Roll, Head Wrap, Kool-Kit, Maxi-Therm Lite, PlastiPad_Gentherm Medical, LLC_Advice regarding use of the device PDF : 164KB | 08/06/2026 Giraffe OmbiBed_Giraffe OmniBed Carestation_Datex-Ohmeda Inc._Advice regarding a device modification PDF : 70KB | 08/06/2026 da Vinci SP Surgical System - Patient Cart_Intuitive Surgical_Advice regarding a device modification PDF : 739KB | 08/06/2026 Harmony Delivery Catheter System_Medtronic, Inc._Advice regarding a device removal PDF : 263KB | 08/06/2026 Exoplan 3.1 Rijeka_ Exocad GmbH_Advice regarding a software upgrade PDF : 1.28MB | 08/06/2026 Homecraft Shower Chair_Performance Health_Advice regarding the use of the device PDF : 191KB | 08/06/2026 Infusion Stopcocks_BD Switzerland Sarl_Advice regarding use of device PDF : 417KB | 08/06/2026 Medline Namic Angiographic Control Syringe with RA_Kimal PLC_Advice regarding a device removal PDF : 266KB | 08/06/2026 Endoflip Systems_Medtronic Inc_Advice regarding the use of the device PDF : 556KB | 08/06/2026 Breathing circuit set coaxial_Hamilton Medical AG_Advice regarding use of the device PDF : 447KB | 08/06/2026 CRE™ Wireguided Balloon Dilatation Catheter_Boston Scientific Corporation_Advice regarding a device removal PDF : 283KB | 08/06/2026 Atlan Family_Dragerwerk AG & Co. KGaA_Advice regarding a device modification PDF : 2.12MB | 08/06/2026 BeneHeart D1 AED_Shenzhen Mindray Bio-Medical Electronics_Advice regarding updates to instructions for use PDF : 299KB | 08/06/2026 Artis Icono Systems_Siemens Healthineers_Advice regarding a software upgrade PDF : 331KB | 08/06/2026 Allura Xper Allura Centron Allura CV20 and MD-Eleva_Philips Medical Systems_Advice regarding the use of the device PDF : 272KB | 08/06/2026 3mensio Workstation Structural Heart 3D Echo Mitral 3D Echo workflow_Pie Medical Imaging_Advice regarding a software upgrade PDF : 312KB | 08/06/2026 SX-ELLA Stent Danis (Danis Stent), Danis Procedure Pack_ELLA-CS, s.r.o._Advice regarding use of a device_ANNEX PDF : 229KB | 08/06/2026 Relay Pro Thoracic Stent Graft System, N4 Non-Bare Stent Configuration 32mm and above_Bolton Medical Inc_Advice regarding a device removal PDF : 223KB | 08/06/2026 VARIOflex abutment set for crown, PF 5.0, H 12.0 mm_Thommen Medical AG_Advice regarding device removal PDF : 196KB | 08/06/2026 Sphere-9 Catheter_Medtronic, Inc._Advice regarding changes or updates made to instructions for use_Follow Up PDF : 208KB | 08/06/2026 SX-ELLA Stent Danis (Danis Stent), Danis Procedure Pack_ELLA-CS, s.r.o._Advice regarding use of a device PDF : 353KB | 08/06/2026 Sidam Srl_Spike_Advice regarding use of a device PDF : 536KB | 08/06/2026 TCN and CSK Reusable Radiofrequency (RF) Electrode_Boston Scientific Neuromodulation Corporation_Advice regarding the removal of the device PDF : 244KB | 08/06/2026 Various MRI Systems_Philips Medical Systems_Advice regarding the use of the device_Updated FSN PDF : 488KB | 08/06/2026 RAPIDLab 348EX Blood Gas System, Siemens Healthcare Diagnostics Manufacturing Ltd, Advice regarding the use of a device PDF : 201KB | 08/06/2026 Relay Pro Thoracic Stent Graft System, N4 Non-Bare Stent Configuration 32mm and above_Bolton Medical Inc._Advice regarding a device removal PDF : 244KB | 08/06/2026 Philips Allura and Azurion_Philips Medical Systems_Advice regarding a device modification_Updated FSN PDF : 482KB | 08/06/2026 Philips Allura and Azurion Systems_Philips Medical Systems Nederland BV_Advice regarding a device modification PDF : 345KB | 08/06/2026