Field Safety Notices: 14 to 18 July 2025
Source: gov.uk (2025-07-22)

List of Field Safety Notices from 14 to 18 July 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 the latest FSNs (https://mhra-gov.filecamp.com/s/o/ncjzW6woOiy3XhOx)

View a list of FSNs published since January 2020 (https://mhra-gov.filecamp.com/s/9g5cLjjFatXruS5U/d)

View FSNs since November 2014 (https://mhra-gov.filecamp.com/s/ZOxdOzRzP22RziUW/fo). FSNs before this date are on the National Archives website (https://webarchive.nationalarchives.gov.uk/*/http:/www.mhra.gov.uk/index.htm)

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 (https://mhra-gov.filecamp.com/s/d/dAbdmZPEleEdk0Fz) 2025/006/xx-xxxx-xxxx

Beckman Coulter: UniCel DxI 600/800 instruments

2 July 2025

Ref. FSN-25050

Model: Refer to FSN

MHRA reference: 36133482 (https://mhra-gov.filecamp.com/s/d/A0VTqR91VN4ainGw) 2025/006/xx-xxxx-xxxx - FSN

MHRA reference: 36133482 (https://mhra-gov.filecamp.com/s/d/mNqZ62AYMxjXBARy) 2025/006/xx-xxxx-xxxx – 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 (https://mhra-gov.filecamp.com/s/d/BudsXtxE16meofap) 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 (https://mhra-gov.filecamp.com/s/d/Kr9B7xQn84ejqVku) Appendix 3 List of impacted lots

MHRA reference: 36144774 (https://mhra-gov.filecamp.com/s/d/Am2RSPss9gpG3sGZ) 2025/004/009/601/087 – Distributor

MHRA reference: 36144774 (https://mhra-gov.filecamp.com/s/d/uNmI1Bx6zoeAIK0L) 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 (https://mhra-gov.filecamp.com/s/d/F1VcXSUrCgQCAn5m) 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 (https://mhra-gov.filecamp.com/s/d/i4Mu7NxAmkFPqZhZ) 2025/007/015/601/044 – Customer reply form

MHRA reference: 36150810 (https://mhra-gov.filecamp.com/s/d/bd2hScglGk5XSDW7) 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 (https://mhra-gov.filecamp.com/s/d/siq46D0t3d9GqiWC)

Interventional Fluoroscopic X-Ray System

Model: Refer to FSN

MHRA reference: 36133209 (https://mhra-gov.filecamp.com/s/d/7I0PoQnBvt2qMrOw) - Group 1: Users with devices shipped until 10-DEC-2024

MHRA reference: 36133209 (https://mhra-gov.filecamp.com/s/d/vqKfWIfulWpTJNoW) - Group 2: Users with devices shipped with the first version of the Addendum to the IFU and Quick Reference Card (QRC)

MHRA reference: 36133209 (https://mhra-gov.filecamp.com/s/d/IaBQk18k7zKEanIZ) - Group 3: Users with Devices shipped with the second version of the Addendum to the IFU and QRC