Medicines Healthcare Products Regulatory Agency
class="gem-c-govspeak govuk-govspeak govuk-!-margin-bottom-0">
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 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