Field Safety Notices: 20 to 24 January 2025
Source: gov.uk (2025-01-29)

List of Field Safety Notices from 20 to 24 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/KcKMRfyTa8FGcOsI)

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)

Defibtech: Defibtech adult or pediatric defibrillation pads

17th January 2025

External defibrillation or electrode

Model: DDP-100, DDP-200P, DDP-2001, DDP-2002

MHRA reference: 34483080 (https://mhra-gov.filecamp.com/s/d/OUR0jVhcOqXJD518) 2025/001/007/601/052

Exmoor: Exmoor Nasal Splints

20th January 2025

Intranasal splint, non-biodegradable

Model: N6

MHRA reference: 34493173 (https://mhra-gov.filecamp.com/s/d/Pwez8ZrDafMO29PA) 2025/001/xx-xxxx-xxxx

Getinge: Heater-Cooler Unit HCU 40 High/Low Voltage

17th January 2025

Heat exchanger, Heart- Lung bypass

Model: 701044054, 701054917

MHRA reference: 34516691 (https://mhra-gov.filecamp.com/s/d/QHmorIHCCZDalp9J) 2025/001/xx-xxxx-xxxx

LivaNova: SenTiva™ VNS Therapy™ Generator

21st January 2025

Model: Model 1000, Model 1000-D

MHRA reference: 34505225 (https://mhra-gov.filecamp.com/s/d/aurTSuCI05019296) 2025/001/xx-xxxx-xxxx

LivaNova: SenTiva™ VNS Therapy™ Generator

21st January 2025

Model: Model 1000, Model 1000-D

MHRA reference: 34506619 (https://mhra-gov.filecamp.com/s/d/5OuqfuGdT6j6ywcM) 2025/001/xx-xxxx-xxxx - Letter 1

MHRA reference: 34506619 (https://mhra-gov.filecamp.com/s/d/aHJxJDNAfGSgm2fD) 2025/001/xx-xxxx-xxxx - Letter 2

Olympus: High Flow Insufflation Unit

19th August 2024

Laparoscopic insufflators

Model: UHI-4

MHRA reference: 34488874 (https://mhra-gov.filecamp.com/s/d/OZz8cXMVSgs7QQIK) 2024/008/014/601/059

Psyomics: Censeo Digital

22 January 2025

Model: Version 3

MHRA reference: 34517862 (https://mhra-gov.filecamp.com/s/d/EzLebjODMDgP5qcX) 2025/001/xx-xxxx-xxxx

RaySearch Laboratories: RayStation

17th January 2025

Various Radiotherapy Instruments – Software

Model: 4.5-2024B including some service packs

MHRA reference: 34483955 (https://mhra-gov.filecamp.com/s/d/4iawWviCEJFKdC7g) 2025/001/017/601/016

Spectrum Medical: Quantum Perfusion Centrifugal Blood Pump

17th January 2025

Cardiopulmonary bypass system centrifugal pump

Model: Quantum Perfusion Centrifugal Blood Pump with Integrated Sensors

MHRA reference: 34505600 (https://mhra-gov.filecamp.com/s/d/AB9LlfgkmhOrTCn2) 2025/001/xx-xxxx-xxxx

US Endodontics: Multiple devices, see product list attached

2nd February 2020

Rotary/reciprocating endo file/rasp, single-use

Model: Multiple model numbers, see product list attached

MHRA reference: 34527242 (https://mhra-gov.filecamp.com/s/d/CajMoWaJEF7aOr8l) 2025/001/008/601/134

Zimmer Biomet: NexGen® Legacy® Constrained Condylar Knee

23rd January 2025

Tibial insert

Model: 00-5994-022-14 and 00-5994-032-10

MHRA reference: 34527012 (https://mhra-gov.filecamp.com/s/d/fFtWg5hPtvUVzo32) 2025/001/xx-xxxx-xxxx