Field Safety Notices: 8 to 12 September 2025
List of Field Safety Notices from 8 to 12 September 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)
21st August 2025
Intracardiac circulatory assist axial-pump catheter
Model: 0042-0000
MHRA reference: 36670459 2025/008/022/601/038
Beckman Coulter, Inc: CellMek SPS
3rd September 2025
AUTOSAMPLERS
MHRA reference: 36679934 2025/009/001/601/022
Drive Medical GmbH: AeroWalk Rollator / Drive DeVilbiss
1st September 2025
Walking aid
Model: 7202000X0
MHRA reference: 36650921 2025/008/019/601/057
EO Laboratories Ltd: Cooked Meat with Brain Heart Infusion Broth Overlay
4th September 2025
Enriched broth culture medium IVD
MHRA reference: 36658088 2025/009/005/601/045
Maquet Cardiopulmonary GmbH: Heater Unit HU 35
11th September 2025
Heat exchanger, Heart-Lung bypass
Model: 701072162, 701072163
MHRA reference: 36699824 2025/009/011/601/054
Maquet Cardiovascular, LLC: VASOVIEW HEMOPRO 2
July 2025
MHRA reference: 36696922 2025/003/011/601/068
MicroVention Europe SARL: RENZAN™ Peripheral Stent System
3rd September 2025
MHRA reference: 36689592 2025/009/010/601/031
Olympus Medical Systems Corporation : Flexible video bronchoscope, reusable
11th September 2025
Model: See attached Excel Spreadsheet
MHRA reference: 36658074 2025/009/005/601/040
Philips Medical Systems Nederland BV: Allura Xper, Allura CV20.
3rd September 2025
Stationary angiographic x-ray system, digital
Model: 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722015, 722020, 722022, 722023, 722025, 722026, 722027, 722028, 722029, 722031, 722033, 722035, 722038, 722039, 722058, 722059
MHRA reference: 36658087 2025/009/005/601/056