Field Safety Notices: 26 to 30 May 2025
Source: gov.uk (2025-06-03)

List of Field Safety Notices from 26 to 30 May 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/FmzpkyYifWcOeErf)

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)

Beckman Coulter: Access Erythropoietin (EPO)

14 May 2025

Description: Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay

MHRA reference: 35717607 (https://mhra-gov.filecamp.com/s/d/JxbLXuzKiejdFZ70) 2025/005/xx-xxxx-xxxx

Becton, Dickinson: BD FACS 7-Color Setup Beads

03 June 2025

Description: Optical instrument performance standard calibrator

MHRA reference: 35754068 (https://mhra-gov.filecamp.com/s/d/v81ekhkl64hD63FG) 2025/005/xx-xxxx-xxxx

Belmont Medical Technologies: Allon

28 May 2025

Description: Circulating-fluid whole- body heating/cooling syst

MHRA reference: 35729211 (https://mhra-gov.filecamp.com/s/d/MOrWQbyrYzPYGvyq) 2025/005/xx-xxxx-xxxx

BioFire Diagnostics: BIOFIRE BCID2 Panel

June 2025

Description: Bloodstream infection-associates microorganism nuc

Model: RFIT-ASY-0147

MHRA reference: 35753777 (https://mhra-gov.filecamp.com/s/d/WKlOBUOSiHB1YrbO) 2025/005/xx-xxxx-xxxx

Canon Medical Systems Corporation: Canon MR System MRT-1550/xx s/n 1A serial number 1.5T MR System

26 May 2025

Description: Full-body MRI system, superconducting magnet

Model: Atlas, Titan, Orian, Elan, Galan, Centurian etc.

MHRA reference: 35716914 (https://mhra-gov.filecamp.com/s/d/6hAs6XNT4eUWi6tj) 2025/005/xx-xxxx-xxxx

IdealMed: Ideal Ring Fixator

29 April 2025

Description: External Orthopaedic Fixation System, Reusable

Model: Probably IM1600007

MHRA reference: 35753665 (https://mhra-gov.filecamp.com/s/d/mCPzCPtFVLfywLct) 2025/005/xx-xxxx-xxxx

implantcast GmbH: MUTARS proximal femur and MUTARS proximal femur revision

26 May 2025

Model: 009300013, MPFESTxx, MPFRSTxx, 57600011, 57600011N, 57691211, 59021211, 59021211N, 59031211, 59031211N, 57601116, 57601116N, 57691611, 59021611, 59021611N, 59031611, 59031611N, 57601120, 57601120N, 57692011, 59022011, 59022011N, 59032011, 59032011N, 57601320, 57601320N, 57692013, 59022013, 59022013N, 59032013, 59032013N, 57600512, 57600012

MHRA reference: 35716720 (https://mhra-gov.filecamp.com/s/d/vlqR2lsyQTnamI5M) 2025/005/xx-xxxx-xxxx

Intersurgical: i-View Video Laryngoscope

02 June 2025

Description: Video intubation laryngoscope kit

MHRA reference: 35729259 (https://mhra-gov.filecamp.com/s/d/cuPWwv97Rs4rAlPx) 2025/005/xx-xxxx-xxxx

MEDTRON AG: All consumables produced by MEDTRON AG

20 May 2025

MHRA reference: 35716719 (https://mhra-gov.filecamp.com/s/d/zXfKIq40oGdCDMeB) 2025/005/xx-xxxx-xxxx

QuidelOrtho: VITROS 4600 Chemistry Systems and VITROS 5600 and XT 7600 Integrated Systems

Reference: CL2025-111

Description: Multiple clinical chemistry analyser IVD lab

MHRA reference: 35729152 (https://mhra-gov.filecamp.com/s/d/bgRzACo58QWWNWkb) 2025/005/xx-xxxx-xxxx