Field Safety Notices: 14 to 18 July 2025
Read the official alert on GOV.UK — MedRegWatch re-presents it; GOV.UK is the authoritative source.
| Type | Field safety notice (devices) |
|---|---|
| Issued | 22 Jul 2025 |
Overview
If you receive a field safety notice (FSN) from a manufacturer you must always act on it.
MHRA publishes the following for information only.
If you have a question about a particular FSN contact the manufacturer.
Latest FSNs
View a list of FSNs published since January 2020
View FSNs since November 2014. FSNs before this date are on the National Archives website
Abiomed, Inc.: Automated Impella Controller (AIC)
3 July 2025
FSN Ref: 2025-FSN-000103
Intracardiac circulatory assist axial-pump catheter
Model: Refer to FSN
MHRA reference: 36181097 2025/006/021/601/001
Beckman Coulter: UniCel DxI 600/800 instruments
2 July 2025
Ref. FSN-25050
Model: Refer to FSN
MHRA reference: 36133482 2025/006/030/601/056 - FSN
MHRA reference: 36133482 2025/006/030/601/056 – Vigilance response form
BioFire Diagnostics/bioMérieux: BIOFIRE® FILMARRAY® TORCH System
19 July 2025
bioMérieux Reference: FSCA 5761-3
Thermal cycler nucleic acid amplification analyzer
Model: Refer to FSN
MHRA reference: 36140498 2025/007/014/601/069
Integra LifeSciences: CODMAN® Disposable Perforator 14mm/ CODMAN® Craniotomy Kit
11 April 2025
Automatic cranial perforator, single-use
Model: Refer to FSN
MHRA reference: 36144774 Appendix 3 List of impacted lots
MHRA reference: 36144774 2025/004/009/601/087 – Distributor
MHRA reference: 36144774 2025/004/009/601/087 – Hospital
LTA MEDICAL/Getinge: Single use endoscope cleaning brush
February 2025
EN.M2.0051
Cleaning flexible endoscopes
Model: Refer to FSN
MHRA reference: 36062963 2025/006/017/601/053
Maquet GmbH/Getinge: Corin Operating Tables
10 July 2025
FSCA 2025-013
Universal operating table, electromechanical
Model: Refer to FSN
MHRA reference: 36150810 2025/007/015/601/044 – Customer reply form
MHRA reference: 36150810 2025/007/015/601/044 – FSN
Philips Medical Systems: Philips Allura and Azurion – UPDATED FSN
19 May 2025
UPDATE to FSN dated 13-Jan-2025 (ref.2023-IGT-BST-015) MHRA ref 34541725
Interventional Fluoroscopic X-Ray System
Model: Refer to FSN
MHRA reference: 36133209 - Group 1: Users with devices shipped until 10-DEC-2024
MHRA reference: 36133209 - Group 2: Users with devices shipped with the first version of the Addendum to the IFU and Quick Reference Card (QRC)
MHRA reference: 36133209 - Group 3: Users with Devices shipped with the second version of the Addendum to the IFU and QRC