Summary of Field Safety Notices August 2026

02/09/2026
Medical devices Summary of field safety notices (FSN)

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

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

Documents

Aisys and AisysCS2 -Datex-Ohmeda Inc- Field Safety Notice- 27 August 2026- Advice regarding the use of the device PDF : 312KB | 27/08/2026 ALPHAMAQUET Operating Table Columns - MAQUET GmbH - Field Safety Notice - 07 August 2026 - Advice regarding a device modification PDF : 305KB | 07/08/2026 Atellica CH Revised C-Reactive Protein (RCRP) - Siemens Healthcare Diagnostics Inc US - Field Safety Notice - 13 August 2026 - Advice regarding the use of the device PDF : 800KB | 13/08/2026 Auto Suture Structural Balloon Trocar and Auto Suture Blunt Tip Trocar - Covidien LLC - Field Safety Notice - 26 August 2026 - Advice regarding updates made to instructions for use PDF : 182KB | 26/08/2026 BIOFIRE FILMARRAY TORCH Base - BioFire Diagnostics - Field Safety Notice - 10 August 2026 - Advice regarding a device modification PDF : 507KB | 10/08/2026 Breathing Circuit set, coaxial-Hamilton Medical AG-Field Safety Notice for distributors-21 July 2026-Advice regarding use of device PDF : 547KB | 21/07/2026 Breathing Circuit set, coaxial-Hamilton Medical AG-Field Safety Notice for Healthcare professionals-21 July 2026-Advice regarding use of device PDF : 542KB | 21/07/2026 CARDIOROOT Woven - Intervascular SAS - Field Safety Notcie - 20 August 2026 - Advice regardinga device removal PDF : 550KB | 20/08/2026 Ouantum pureflow standard heat exchanger_Spectrum Medical s.r.l._Field Safety Notice _ 17th August 2026 PDF : 328KB | 17/08/2026 Neisseria meningitidis Gp C 2mlVL - Remel Inc - Field Safety Notice - 12 August 2026 - Advice regarding a device removal PDF : 376KB | 12/08/2026 IV Sets or Administration Sets- ICU Medical-Field Safety Notice-14 August 2026-Advice regarding use of the device PDF : 343KB | 14/08/2026 Imager II Angiographic Catheter - Boston Scientific Corporation - Field Safety Notice - 24 August 2026 - Advice regarding a device removal PDF : 386KB | 24/08/2026 High Voltage X-Ray Generator used with various systems - Shimadzu Corporation - Field Safety Notice - 22 June 2026 - Advice regarding a device modification PDF : 380KB | 22/06/2026 ForeSight Oximeter cable - Edwards Lifesciences - Field Safety Notice - 11 August 2026 - Advice regarding the use of the device PDF : 298KB | 11/08/2026 Carts for LUNA X5 Winncare ceiling lift - Winncare Nordic ApS - Field Safety Notice - 27 July 2026 - Advice regarding a device modification PDF : 749KB | 27/07/2026 e-motion M25 - Alber GmbH - Field Safety Notice - 22 June 2026 - Advice regarding the use of the device PDF : 150KB | 22/06/2026 Patient Information Center iX (PIC iX) - Philips - Field Safety Notice - 31 July 2026 - Advice regarding a software upgrade PDF : 156KB | 31/07/2026 StatStrip Glucose Hospital Meter System - Nova Biomedical Corporation - Field Safety Notice - 05 August 2026 - Advice regarding the use of the device PDF : 286KB | 05/08/2026 Smartbag- liquid acid concentrates_Fresenius Medical Care_Field Safety Notice_ 31 July 2026 PDF : 1.3MB | 31/07/2026 VentStar Resus Neo, VentStar Resuscitaire-Drägerwerk AG & Co. KGaA-Field Safety Notice-August 2026-Advice regarding the use of the device PDF : 332KB | 31/08/2026 StrykeFlow PS and AHTO - Stryker Endoscopy - Field Safety Notice - 27 August 2026 - Advice regarding a device removal PDF : 298KB | 27/08/2026