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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 . FSNs before this date are on the

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: ÌýÌý 2025/006/021/601/001

Beckman Coulter: UniCel DxI 600/800 instruments

2 July 2025

Ref. FSN-25050

Model: Refer to FSN

MHRA reference:    2025/006/030/601/056 - FSN

MHRA reference: ÌýÌý 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: ÌýÌý 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: ÌýÌý Appendix 3 List of impacted lots

MHRA reference: ÌýÌý 2025/004/009/601/087 – Distributor

MHRA reference: ÌýÌý 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: ÌýÌý 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: ÌýÌý 2025/007/015/601/044 – Customer reply form

MHRA reference: ÌýÌý 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 ÌýÌý

Interventional Fluoroscopic X-Ray System

Model: Refer to FSN

MHRA reference: - Group 1: Users with devices shipped until 10-DEC-2024

MHRA reference: - Group 2: Users with devices shipped with the first version of the Addendum to the IFU and Quick Reference Card (QRC)

MHRA reference: - Group 3: Users with Devices shipped with the second version of the Addendum to the IFU and QRC