Summary of Field Safety Notices September 2026

14/10/2026
Medical devices Summary of field safety notices (FSN)

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

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

Documents

Centricity PACS; Enterprise Archive - GE Healthcare - Field Safety Notice - 07 September 2026 - Advice regarding the use of the device PDF : 158KB | 07/09/2026 Bravo CF capsule delivery device - Medtronic - Field Safety Notice - August 2026 - Advice regarding a device removal PDF : 436KB | 31/08/2026 da Vinci X or Xi Reusable Instrument Grip Cables - Intuitive Surgical, Inc. - Field Safety Notice - 03 September 2026 - Advice regarding a device removal - Follow Up FSN 2 PDF : 815KB | 03/09/2026 Direxion and Direxion HI-FLO Torqueable Microcather - Boston Scientific Corporation - Field Safety Notice - 16 September 2026 - Advice regarding a device removal PDF : 264KB | 16/09/2026 DORMO-STRIP Single-Use Vein Stripper - Telic S.A.U. - Field Safety Notice - 22 September 2026 - Advice regarding a device removal PDF : 150KB | 22/09/2026 Dexcom G7 iOS CGM App-Dexcom Inc.Field Safety Notice-22 September 2026-Advice regarding software update PDF : 145KB | 22/09/2026 Carescape™ Central Station (CSCS) V3.0.x - GE HealthCare - Field Safety Notice - 28 August 2026 - Advice regarding changes_updates made to instructions for use PDF : 331KB | 14/10/2026 Centricity High Acuity Anaesthesia-GE Healthcare Finland OY-Field Safety Notice-07 September 2026 PDF : 201KB | 07/09/2026 Carestation 850, Carestation 850c_GE Healthcare_Field Safety Notice_31st August_advice regarding use of device PDF : 303KB | 31/08/2026 True Metrix Air and True Metrix Go - Trividia Health - Field Safety Notice - 21 August 2026 - Advice regarding the use of the device PDF : 260KB | 21/08/2026 CareLink SmartSync Micra AV2-VR2 Application software D00U022 - Medtronic Inc. - Field Safety Notice - September 2026 - Advice regarding a software upgrade PDF : 496KB | 30/09/2026 CareLink SmartSync Common Application M01A02 - Medtronic Inc. - Field Safety Notice - September 2026 - Advice regarding a software upgrade PDF : 415KB | 14/10/2026 Spike-Sidam Srl-Field Safety Notice-31 July 2026-Advice regarding the use of a device PDF : 520KB | 31/07/2026 Automated Impella Controller - Abiomed - Field Safety Notice - 01 August 2026 - Advice regarding changes_updates made to instructions for use PDF : 310KB | 01/08/2026 AMPLATZER™ Amulet LAA Occluder - Abbott Medical - Field Safety Notice - 11 September 2026 - Advice regarding updates made to instructions for use PDF : 125KB | 11/09/2026 Atellica CH HDL Cholesterol and Atellica CH Total Protein II - Siemens Healthineers - Field Safety Notice - September 2026 - Advice regarding the use of the device PDF : 262KB | 30/09/2026 NDI Passive Sphere™, Medtronic Biopsy Needle Kit - Northern Digital Inc. - 2 September 2026 - Advice regarding a device removal PDF : 332KB | 02/09/2026 PALACOS R G pro, PALACOS MV G pro, COPAL G C pro - Heraeus Medical GmbH - Field Safety Notice - 03 September 2026 - Advice regarding changes or updates made to instructions for use PDF : 111KB | 03/09/2026 OmniaSecure MRI SureScan 3930M Lead - Medtronic Inc. - Field Safety Notice - September 2026 - Advice regarding a device removal PDF : 346KB | 30/09/2026 NOxBOXi_ NOxBOX_Field Safety Notice_ 19th August 2026_Advice regarding use of Device PDF : 503KB | 19/08/2026 SOLTIVE™ Laser Fiber Products - Field Safety Notice - 16 September 2026 - Olympus Gyrus ACMI, Inc. - Advice regarding a device removal PDF : 733KB | 16/09/2026 SOLTIVE™ Laser Fiber Products (UPDATE) - Field Safety Notice - 1 October 2026 - Olympus Gyrus ACMI, Inc. - Advice regarding a device removal PDF : 770KB | 01/10/2026 Various Products - CRN00HKJ0 - Field Safety Notice - 02 September 2026 - Advice regarding a device removal PDF : 807KB | 02/09/2026 NGPod - NGPod Global Limited - Field Safety Notice - 09 September 2026 - Advice regarding a device removal PDF : 173KB | 09/09/2026 InstAlert hCG One Step Pregnancy Test Strip (Urine) and SureStep hCG One Step Pregnancy Test Device (Urine) - Alere San Diego dba Innovacon - Field Safety Notice - 23 September 2 PDF : 366KB | 23/09/2026 MRI systems with Diffusion Tensor Imaging - Philips - Field Safety Notice - September 2026 - Advice regarding the use of the device PDF : 326KB | 30/09/2026 IntelliVue Patient Monitors - Philips - Field Safety Notice - 25 August 2026 - Advice regarding a software upgrade PDF : 329KB | 25/08/2026 CitraLock Syringe 4% - Sterisets Manufacturing - Field Safety Notice - 28th september 2026 - Advise regarding removal of device PDF : 388KB | 28/09/2026 BiCOAG Hemostasis Probe - Gyrus ACMI, Inc. - Field Safety Notice - 03 September 2026 - Advice regarding a device removal PDF : 286KB | 03/09/2026 IntelePACS-InteleConnect Portal-Technologist Portal - Intelerad Medical Systems - Field Safety Notice - 9 September 2026 - Advice regarding the use of the device PDF : 679KB | 14/10/2026 MR Systems with SW versions R5 & R11 - Philips - Field Safety Notice - August 2026 - Advice regarding the use of the device PDF : 330KB | 31/08/2026 Carevo - ArjoHuntleigh AB - Field Safety Notice - 14 September 2026 - Advice regarding changes_updates made to instructions for use PDF : 548KB | 14/09/2026 Dexcom G7 iOS CGM App-Dexcom Inc.-Field Safety Notice-09 September 2026-Advice regarding software update PDF : 142KB | 09/09/2026 EntericBio® Viral Panel 3 - Serosep Ltd - Field Safety Notice - 14 September 2026 - Advice regarding the use of the device PDF : 654KB | 14/09/2026