Summary of Field Safety Notices October 2026

13/11/2026
Medical devices Summary of field safety notices (FSN)

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

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

Documents

Cobas c 303 analytical unit - Roche Diagnostics GmBH - Field Safety Notice - 22 September 2026 - Advice regarding the use of the device PDF : 27KB | 22/09/2026 Atellica CH Diazo Total Bilirubin (D_TBil) - Initial and Follow Up FSN - Siemens Healthcare Diagnostics Inc - Field Safety Notice - 16 October 2026 - Advice regarding the use of the device PDF : 667KB | 16/10/2026 Batec Handbikes ELECTRIC, RAPID 2, and SCRAMBLER 2 - Batec Mobility - Field Safety Notice - 06 October 2026 - Advice regarding a device modification PDF : 547KB | 06/10/2026 Abre™ Venous Self-expanding Stent System - Medtronic, Inc. - Field Safety Notice - 14 October 2026 - Advice regarding the use of the device PDF : 291KB | 14/10/2026 Aerstent TBY - Bess Pro GmbH - Field Safety Notice - 23 September 2026 - Advice regarding a device removal PDF : 380KB | 23/09/2026 Carestation 850 and 850c Anesthesia Systems  - Datex-Ohmeda, Inc - Field Safety Notice - 28 October 2026 - Advice regarding the use of the device PDF : 211KB | 28/10/2026 cobas c 703 - Roche Diagnostics GmBH - Field Safety Notice - 29 September 2026 - Advice regarding a device modification PDF : 218KB | 29/09/2026 Corpuls3 - Corpuls - Field Safety Notice - 30 September 2026 - Advice regarding a device modification PDF : 358KB | 30/09/2026 EMAG - bioMérieux SA - Field Safety Notice - 08 October 2026 - Advice regarding the use of the device PDF : 432KB | 08/10/2026 KayserBett IDA, EMMA, and OLAF - KayserBetten - Field Safety Notice - 09 October 2026 - Advice regarding a device modification PDF : 67KB | 09/10/2026 i-STAT hs-TnI cartridge - Abbott Point of Care USA - Field Safety Notice - 20 October 2026 - Advice regarding the use of the device PDF : 139KB | 20/10/2026 Likorall Ceiling-Mounted Overhead Patient Lift System - Baxter - Field Safety Notice - 07 October 2026 - Advice regarding a device modification PDF : 173KB | 07/10/2026 Lumify Diagnostic Ultrasound System - Philips - Field Safety Notice - 02 October 2026 - Advice regarding the use of the device PDF : 210KB | 02/10/2026 InterPulse - Stryker Instruments USA - Field Safety Notice - 30 September 2026 - Advice regarding updates made to instructions for use PDF : 227KB | 30/09/2026 HeartSine® samaritan® PAD - Stryker - Field Safety Notice - 03 September 2026 - Advice regarding a device removal PDF : 227KB | 03/11/2026 ESENTA Stomahesive Paste  - Convatec Ltd - Field Safety Notice - 12 October 2026 - Advice regarding a device removal PDF : 533KB | 12/10/2026 IntelePACS - Intelerad - Field Safety Notice - 15 September 2026 - Advice regarding a software upgrade PDF : 506KB | 15/09/2026 HF Cables (Reusable) - Olympus Winter & Ibe GmbH - Field Safety Notice - 20 October 2026 - Advice regarding the use of the device PDF : 757KB | 20/10/2026 OptiCross IVUS Imaging Catheters - Boston Scientific Corporation - Field Safety Notice - 22 October 2026 - Advice regarding changes-updates made to instructions for use PDF : 286KB | 22/10/2026 Precision pointer Electromagnetic - Stryker Leibinger GmbH & Co. KG - Field Safety Notice - 22 September 2026 - Advice regarding a device removal PDF : 454KB | 22/09/2026 Panocell®-20 - Immucor, Inc (Werfen) - Field Safety Notice - 19 October 2026 - Advice regarding the use of the PDF : 223KB | 19/10/2026 Philips Allura Xper Systems with FlexVision monitor - Philips - Field Safety Notice - 1 October 2026 - advice regarding the use of the device PDF : 256KB | 01/10/2026 SMOOTHBORE BREATHING SYSTEMS - IntersurgicaL Ltd. - Field Safety Notice - 28 October 2026 - Advice regarding a device removal PDF : 210KB | 28/10/2026 ORTHO™ Sera Anti-Fyb - Alba Bioscience Limited (Alive Dx) - Field Safety Notice - 28 September 2026 - Advice reg PDF : 316KB | 28/09/2026 Ophthalmic knife, single-use - Beaver-Visitec International, Inc. US - Field Safety Notice - 2nd November 2026 - Advice regarding a device removal PDF : 147KB | 02/11/2026 STERIFLUSH NaCl prefilled syringes._Raffin Medical_Field safety Notice _17th October 2026_Advise regarding removal of the device PDF : 712KB | 17/10/2026 StatStrip Ketone Strips - Nova Biomedical - Field Safety Notice - 14 October 2026 - Advice regarding a device removal PDF : 377KB | 14/10/2026 Primestore MTM - Longhorn Vaccines and Diagnostics, LLC USA - Field Safety Notice - 28 September 2026 - Advice regarding a device removal PDF : 238KB | 28/09/2026 Namic Kit - ArcRoyal - Field Safety Notice - 13 October 2026 - Advice regarding a device removal PDF : 221KB | 13/10/2026 Spectral CT with software version 5.0, 5.2 or 5.4 - Philips - Field Safety Notice - 4 September 2026 - advice regarding a software upgrade PDF : 448KB | 04/09/2026 Medifa - Medifa GmbH - Field Safety Notice - 13 October 2026 - Advice regarding a device modification PDF : 1.09MB | 12/11/2026 TRANSONIC Sterile ultrasound gel - TELIC, S.A.U. Spain - Field Safety Notice - 19th October 2026 - Advice regarding a device removal PDF : 148KB | 19/10/2026 Spike - Sidam Srl - Field Safety Notice - 24 September 2026 - Advice regarding the use of the device PDF : 1.38MB | 24/09/2026 Metal orthodontic devices - American Orthodontics - Field Safety Notice - Advice regarding updates made to instructions for use PDF : 828KB | 12/11/2026