Field Safety Notices: 29 September to 3 October 2025
List of Field Safety Notices from 29 September to 3 October 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
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