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Field Safety Notices: 29 September to 3 October 2025

Read the official alert on GOV.UK — MedRegWatch re-presents it; GOV.UK is the authoritative source.

TypeField safety notice (devices)
Issued7 Oct 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

View a list of FSNs published since January 2020

View FSNs since November 2014. FSNs before this date are on the National Archives website

Elekta Solutions AB : Leksell Vantage Arc System

September 2025

Stereotactic Surgery System, Neurological

Model: 1040048

MHRA reference: 37201254   2025/009/026/601/071 

GE Medical Systems Information Technologies INC : MAC VU360

FMI 30117

Electrocardiograph, professional, multichannel

MHRA reference: 37220607   2025/010/001/601/078 

Medtronic, Inc: AZURE S DR MRI SureScan

September 2025

MHRA reference: 37211683   2025/004/007/601/088

MHRA reference: 37211683   2025/004/007/601/088 – Customer acknowledgement form  

Philips Medical Systems Nederland BV: Philips Zenition 50

29 September 2025

Interventional Fluoroscopic X-Ray System

Model: See Units Affected List for C&R 2024-IGT-PUN-004

MHRA reference: 37220338  2025/010/001/601/028

Shimadzu/Fujifilm Healthcare: FDR Visionary Suite

25 May 2025

Digital Radiography System

MHRA reference: 37185216    

Straumann AG: Emdogain Course

24 September 2025

Model: Emdogain Course

MHRA reference: 37196497   2025/009/025/601/050 

Terumo BCT, Inc: Spectra Optia BMP Set

September 2025

Apheresis System Tubing Set

MHRA reference: 37208142   2025/009/030/601/076

MHRA reference: 37208142   2025/009/030/601/076 – Customer reply form

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