Field Safety Notices: 7 to 11 April 2025
Source: gov.uk (2025-04-15)

List of Field Safety Notices from 7 to 11 April 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/61iJ4U16lQ2p1iAu)

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: DxC 500i Clinical Analyzer

28 March 2025

See Section 8

MHRA reference: 35268343 (https://mhra-gov.filecamp.com/s/d/Y90PyUdUxSH51wr4) 2025/004/008/601/120

Farla Medical Ltd: Instramed

3 April 2025

MHRA reference: 35268659 (https://mhra-gov.filecamp.com/s/d/P8sJ64ddcQbLIE9E) 2025/004/008/601/023

Fresenius Kabi AG: COMPOSTOP FLEX 2F PLT PROC. LEUKO RED.

2 April 2025

MHRA reference: 35246323 (https://mhra-gov.filecamp.com/s/d/8Pw5a9UDQL1xsGWZ) 2025/003/xx-xxxx-xxxx

Galt Medical Corp: Guidewire Introducer Needle & Guidewire

1649395-03-28-2025-001-R

Vascular Catheter Introduction Needle

MHRA reference: 35280507 (https://mhra-gov.filecamp.com/s/d/jLQ0X2giunqBY2cN) 2025/004/009/601/076

MHRA reference: 35280507 (https://mhra-gov.filecamp.com/s/d/kPcmO6mxvAgmVYGb) 2025/004/009/601/076

GE Medical Systems Ultrasound and Primary Care Diagnostics: Venue Go, Venue Fit

FMI 78101

Ultrasound system, imaging, general-purpose

MHRA reference: 35268407 (https://mhra-gov.filecamp.com/s/d/nNe0orNPnz50wxvQ) 2025/004/008/601/113

IBA Dosimetry GmbH: myQA iON

24 March 2025

MHRA reference: 35268441 (https://mhra-gov.filecamp.com/s/d/0TCZgFzybmfXXOrw) 2025/004/007/601/081

Intuitive Surgical: Ion Endoluminal System

ISIFA2025-05-C

Surgical planning/navigation-enhancement system

Model: 380748

MHRA reference: 35280444 (https://mhra-gov.filecamp.com/s/d/jc40cFzpTuNsfCt9) 2025/004/009/601/027

iSTAR Medical SA: MINIject S

Glaucoma supraciliary implant

MHRA reference: 35246751 (https://mhra-gov.filecamp.com/s/d/ARVVkwGHDViyVWX0) 2024/009/006/601/052

Maquet Cardiovascular, LLC: VASOVIEW HEMOPRO 2

March 2025

Model: VH-4000, VH-4001

MHRA reference: 35268041 (https://mhra-gov.filecamp.com/s/d/VUAGViVmqFaDkeFY) 2025/004/008/601/151

Roche Diabetes Care Gmbh: Accu-Chek Spirit 3.15 ml cartridge system

SB_RDC_2024_05

PORTABLE MICRO INFUSION INSTRUMENTS – CONSUMABLES

MHRA reference: 35268206 (https://mhra-gov.filecamp.com/s/d/e9xVWZEem2NPlfkZ) 2025/004/008/601/144 – Healthcare Professionals

MHRA reference: 35268206 (https://mhra-gov.filecamp.com/s/d/WZzCia8NCgDix0hl) 2025/004/008/601/144 – Retailer/ Distributer

MHRA reference: 35268206 (https://mhra-gov.filecamp.com/s/d/uYkxGpDNBmSYW0GY) 2025/004/008/601/144 - Accu-Chek Spirit 3.15 ml cartridge Users

SCHILLER AG: FRED easyport

1 April 2025

Non-rechargeable professional semi-automated exter

Model: 3.940050

MHRA reference: 35285091 (https://mhra-gov.filecamp.com/s/d/bS0JkCIfVcFlDFER) 2025/003/xx-xxxx-xxxx

Welch Allyn: Refer to section 8 “Comments”

4 April 2025

Refer to section 8 “Comments”

MHRA reference: 35246244 (https://mhra-gov.filecamp.com/s/d/zqEteiAXDj5njo7E) 2025/004/004/601/045

MHRA reference: 35246244 (https://mhra-gov.filecamp.com/s/d/V1BEf2sv1W6hclDZ) 2025/004/004/601/045 – Customer reply form

MHRA reference: 35246244 (https://mhra-gov.filecamp.com/s/d/69KIYjHr4HfPI9DX) 2025/004/004/601/045 – Attachment A

MHRA reference: 35246244 (https://mhra-gov.filecamp.com/s/d/VCMAe9nCqDgIljJc) 2025/004/004/601/045 – Attachment B