Field Safety Notices: 13 to 17 January 2025
Source: gov.uk (2025-01-22)

List of Field Safety Notices from 13 to 17 January 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/e1zGhYprVtlfVlnh)

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)

Baxter: Braun Pro 6000

26 June 2024

Infrared patient thermometer, ear

Model: Refer to FSN

MHRA reference: 34454081 (https://mhra-gov.filecamp.com/s/d/P2A6q0aDuXMSqCqM) 2024/006/xx-xxxx-xxxx

Baxter: Control-A-Flo Solution Administration Set with Needle Y-site

14 January 2025

FLOW REGULATOR SET

Model: Refer to FSN

MHRA reference: 34440212 (https://mhra-gov.filecamp.com/s/d/bGcfA7j8OexjUJPk) 2025/001/014/601/029

Holmusk Europe: Management and Supervision Tool (MaST)

3 December 2024

MHRA reference: 34494598 (https://mhra-gov.filecamp.com/s/d/tnenF320KMksAjtR)

Illumina: NovaSeq 6000Dx Instrument including DRAGEN Server and Illumina DRAGEN Server for NextSeq 550Dx

16 January 2025

Nucleic acid sequence analyser IVD, NGS

Model: Refer to FSN

MHRA reference: 34465698 (https://mhra-gov.filecamp.com/s/d/gJbOTJDjhO59Lryd) 2025/001/015/601/035

Kirwan: Disposable Bipolar Pencil 25GA Straight

19 November 2024

Model: Refer to FSN

MHRA reference: 34429079 (https://mhra-gov.filecamp.com/s/d/0npshnleaIchGhaI) 2024/011/019/601/046

Loewenstein Medical: Elisa 300, Elisa 500, Elisa 600, Elisa 800VIT

7 January 2025

Critical Care Ventilator

Software update

Model: Refer to FSN

MHRA reference: 34440538 (https://mhra-gov.filecamp.com/s/d/zvbpgCL0DgfqdFj5) BfArM xxxxx/24

Medline: Electrosurgical Electrode - UPDATED FSN

9 January 2025

FSN 24-02

Update to FSN issued in April 2024 – MHRA ref 29296734 (https://mhra-gov.filecamp.com/s/d/0ltTl6fXgAthmPKz)

Additional lot numbers are impacted by this new recall

Model: see Annex 1

MHRA reference: 34402496 (https://mhra-gov.filecamp.com/s/d/dS05M1PSDpLdKWFS) 2024/004/018/601/041

Medtronic: Percept™ PC Implantable Neurostimulator (INS) Model B35200 Unable to be Interrogated – UPDATED FSN

January 2025

Software Update

Medtronic Reference: FA1231

Model: Refer to FSN

MHRA reference: 34458244 (https://mhra-gov.filecamp.com/s/d/h3qkZ3rLxvrvSCGL) 2022/004/001/291/004

Medtronic: Percept™ PC Model B35200 Implantable Neurostimulator (INS) – UPDATED FSN

January 2025

INS Failure After Cardioversion - Software Update

Medtronic Reference: FA1206

Model: Refer to FSN

MHRA reference: 34458194 (https://mhra-gov.filecamp.com/s/d/TLaTH5Z4h7LoNW2F) 2021/010/015/579/002

Philips: Azurion and Allura Xper series – Follow up FSN

15 November 2024

Interventional Fluoroscopic X-Ray System

Follow up to FSN issued in June 2023 - MHRA ref. 5303178 (https://mhra-gov.filecamp.com/s/d/XGFrp5poyfZ3rsDs)

Model: Refer to FSN

MHRA reference: 34417413 (https://mhra-gov.filecamp.com/s/d/PiYErmq1seGgGP1b) 2023/006/008/601/030

Philips: Achieva 1.5T, Achieva 1.5T Conversion, Achieva 1.5

1 October 2024

Magnetic Resonance Imaging (MRI) unit

Model: Refer to FSN

MHRA reference: 34453566 (https://mhra-gov.filecamp.com/s/d/P1niCwuPQ0El18w7) 2024/004/xx-xxxx-xxxx

Philips: Tack Endovascular System

January 2025

Multiple peripheral artery stent, bare metal

Model: Refer to FSN

MHRA reference: 34425077 (https://mhra-gov.filecamp.com/s/d/bCRvHmyODQ1VNmI3) 2025/001/013/601/032

Vygon: LIFECATH PICC+MST DOUBLE 4.5FG B10

10 January 2025

Catheters, Central Venous, Peripherally Inserted

Batch/LOT: 101024GT

MHRA reference: 34424440 (https://mhra-gov.filecamp.com/s/d/zjeZvwnWcrCLu4Gg) 2025/001/013/601/053

Zimmer Biomet: Optipac® Vacuum mixing system

16 January 2025

Orthopaedic cement, antimicrobial

Model: Refer to FSN Attachment 2 - Affected Product List

MHRA reference: 34467376 (https://mhra-gov.filecamp.com/s/d/52b4YJAJRA4Y5tI6) 2025/001/016/601/099