Field Safety Notices: 20 to 24 January 2025

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

View a list of FSNs published since January 2020

View FSNs since November 2014. FSNs before this date are on the National Archives website

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   2025/001/007/601/052 

Exmoor: Exmoor Nasal Splints

20th January 2025

Intranasal splint, non-biodegradable

Model: N6

MHRA reference: 34493173   2025/001/020/601/050 

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

17th January 2025

Heat exchanger, Heart- Lung bypass

Model: 701044054, 701054917

MHRA reference: 34516691   2025/001/023/601/005

LivaNova: SenTiva™ VNS Therapy™ Generator

21st January 2025

Model: Model 1000, Model 1000-D

MHRA reference: 34505225   2025/001/021/601/106 

LivaNova: SenTiva™ VNS Therapy™ Generator

21st January 2025

Model: Model 1000, Model 1000-D

MHRA reference: 34506619   2025/001/021/601/105 - Letter 1

MHRA reference: 34506619   2025/001/021/601/105  - Letter 2

Olympus: High Flow Insufflation Unit

19th August 2024

Laparoscopic insufflators

Model: UHI-4

MHRA reference: 34488874   2024/008/014/601/059 

Psyomics: Censeo Digital

22 January 2025

Model: Version 3

MHRA reference: 34517862   2025/001/022/601/034

RaySearch Laboratories: RayStation

17th January 2025

Various Radiotherapy Instruments – Software

Model: 4.5-2024B including some service packs

MHRA reference: 34483955   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   2025/001/021/601/084  

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    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    2025/001/023/601/037

Updates to this page

Published 29 January 2025