Field Safety Notices: 11 to 15 August 2025
Source: gov.uk (2025-10-28)

List of Field Safety Notices from 11 to 15 August 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/WMkkhSciV4nLs1gr)

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)

Derma Sciences: Medihoney

Date: 5 August 2025

Description: Medical-honey liquid barrier dressing, sterile

MHRA reference: 36416410 (https://mhra-gov.filecamp.com/s/d/sgGUb9xu3UNf3bEP) 2025/007/xx-xxxx-xxxx

Dexcom: Dexcom One, Dexcom G7, and Dexcom One+ Receivers

Date: 18 July 2025

Description: Percutaneous glucose monitoring system

MHRA reference: 36420524 (https://mhra-gov.filecamp.com/s/d/G6YkgDmoIrZhVqrw) 2025/xx-xxxx-xxxx

Max Mobility: SpeedControl Dial used with the Smartdrive MX2+: Updated FSN to supersede 2024/012/011/601/079 (36354122)

Date: 12 August 2025

Description: Manual wheelchair, power assist unit

Model: MX2-3DC

MHRA reference: 36431492 (https://mhra-gov.filecamp.com/s/d/5tvqQuJMGAjsNw5k)

Olympus: TJF-Q190V Evis Exera III Duodenovideoscope

TJF-Q290V Evis Lucera Elite Duodenovideoscope TJF-Q170V Duodenovideoscope

Date:14 May 2025

Description: Flexible video duodenoscope, reusable

Model: TJF-Q190V, TJF-Q290V, TJF-Q170V

MHRA reference: 36443422 (https://mhra-gov.filecamp.com/s/d/zDOLZL3ts4s76J14)

Orthofix: HALF PIN L120MM D4.0MM THREAD D4.0XL18MM PACK OF 2

Date: 25 July 2025

MHRA reference: 36416572 (https://mhra-gov.filecamp.com/s/d/7Ll0lIHI16HwiCV4) 2025/007/xx-xxxx-xxxx

Shenzhen Mindray bio-medical electronics: Patient Monitor

Date: 11 August 2025

Model: BeneVision N1

MHRA reference: 36429373 (https://mhra-gov.filecamp.com/s/d/c15Ns2CZlkgEPnMm) 2025/008/011/601/047

Siemens Healthcare: 3 Tesla MRI system

Date: 5 August 2025

MRI system, full body

MHRA reference: 36415735 (https://mhra-gov.filecamp.com/s/d/DbWxQPzsjPPjD7tq) and 37438832 (https://mhra-gov.filecamp.com/s/d/EVxMeC8UHkYbDJj3) 2025/008/008/601/052 FSN

Follow up FSNs 37438860 (https://mhra-gov.filecamp.com/s/d/aIeLCmUPyA3OUXEB) or 37438867 (https://mhra-gov.filecamp.com/s/d/du3Tl2AFurTtjM2D) depending on the outcome of the inspection

MHRA reference: 36415735 (https://mhra-gov.filecamp.com/s/d/z8aXCeZnqfq9WQGM), 37438832 (https://mhra-gov.filecamp.com/s/d/vmhh70VyC6QZuKyZ), 37438860 (https://mhra-gov.filecamp.com/s/d/euWAuXEQ1kyr1VM4), 37438867 (https://mhra-gov.filecamp.com/s/d/bb3yQIKKPaBuIDGK), 2025/008/008/601/052 - Acknowledgment of Receipt

Siemens: ARTIS pheno

Date: August 2025

Description: Stationary angiographic x-ray system, digital

MHRA reference: 36462683 (https://mhra-gov.filecamp.com/s/d/1BnA6fZvSVr89PFC) 2025/008/008/601/057

Siemens: 3 Tesla MRI system

12 August 2025

MRI system, full body

MHRA reference: 37328410 (https://mhra-gov.filecamp.com/s/d/UNP5RyQpHt3Yclnn) 2025/010/008/601/001, FSN MR041/25/S (https://mhra-gov.filecamp.com/s/d/UNP5RyQpHt3Yclnn) and FSN MR066/025/S (https://mhra-gov.filecamp.com/s/d/AZo05Te2cDIORr5G) [further update to MR 041/25/S]

Followed up by FSN MR047/25/S (https://mhra-gov.filecamp.com/s/d/v4V0SOrz1oD2h65W) or FSN MR053/25S (https://mhra-gov.filecamp.com/s/d/D4db7gF5yLDL20Ni), depending on the outcome of the inspection.

Stryker: System 6/7/8/9 Reciprocating / Sternum Saw

Date: 06 March 2025

MHRA reference: 36435194 (https://mhra-gov.filecamp.com/s/d/rBUXeeK7vH58jJ7I) 2025/004/004/601/051

Waldemar Link: Endo-Model - M, GEMINI SL, CustomLINK

Date: 08 August 2025

Description: Uncoated knee tibia/insert prosthesis

Model: 15-2814/0315-2815/11318-316/0311C009635313-0583411C009405313-08644

MHRA reference: 36414418 (https://mhra-gov.filecamp.com/s/d/sOnWF40uWoQ3FpIe) 2025/008/008/601/058