Field Safety Notices: 13 to 17 October 2025
Source: gov.uk (2025-10-21)

List of Field Safety Notices from 13 to 17 October 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/QHNa1ZcdXIUqOhwz)

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)

Abbott: CentriMag Blood Pump

October 2025 FA-Q325-HF-2

Cardiopulmonary bypass system centrifugal pump

Model: 201-90010, CMAEK01

MHRA reference: 37370240 (https://mhra-gov.filecamp.com/s/d/X2aRGO7GLKGx3Ahj) 2025/010/015/601/030

Abbott: HeartMate II and HeartMate3 System Controllers

October 2025

Heart Ventricle Prosthesis

Model: 106017, 106524INT, 106531INT, 106531LF2

MHRA reference: 37369973 (https://mhra-gov.filecamp.com/s/d/fPh2LceGg7ZM2pO5) 2025/010/015/601/020

GE Medical Systems: CARESCAPE Central Station

FMI 36167

Centralized Patient Monitor

MHRA reference: 37309225 (https://mhra-gov.filecamp.com/s/d/KFYI58cCmnodjEFu) 2025/009/xx-xxxx-xxxx

Gyrus: ShockPulse Lithotripsy Transducer, ShockPulse-SE Lithotripsy System

20 October 2025

Pneumatic/ultrasonic lithotripsy system, Ultrasonic lithotripsy system probe, reusable Model: SPL-T, SPL-SR

MHRA reference: 37338652 (https://mhra-gov.filecamp.com/s/d/atgYOxhwpdzk7cJW) 2025/010/013/601/080

ICU Medical: CADD-Solis Ambulatory Infusion Pumps

16 October 2025

Bedside infusion pump, single-channel

Model: CADD-Solis VIP

MHRA reference: 37337852 (https://mhra-gov.filecamp.com/s/d/JRAewYEeFFyPaHiL) 2025/010/013/601/015

Implant Restorations: G7 Acetabular System

13 October 2025

Non-constrained polyethylene acetabular liner

Model: 110031012; 110031013

MHRA reference: 37344143 (https://mhra-gov.filecamp.com/s/d/VTt2UkmblXsP0TIa) 2025/010/013/601/077

Intuitive Surgical: da Vinci Xi and da Vinci X Surgical System

ISIFA2022-14-C

Robotic Surgical System

Model: IS4000 Surgical System; IS4200 Surgical System

MHRA reference: 37384311 (https://mhra-gov.filecamp.com/s/d/wX26W67ZbHMNWBc0)

Masimo: RAd-G Pulse Oximeter

25 August 2025

Pulse oximeter

MHRA reference: 37349813 (https://mhra-gov.filecamp.com/s/d/rKEP6hhx3lOY7pSr) 2024/003/xx-xxxx-xxxx

Osatu S.Coop: REANIBEX300, REANIBEX500/BEXEN CARDIO/OSATU S.COOP

06 October 2025

47910-External Defibrillator;17882-Monitor Defi.

MHRA reference: 37338804 (https://mhra-gov.filecamp.com/s/d/dyWbne8mXsfI1w7Z)

Recordati: Caphosol

24 June 2025

artificial saliva

MHRA reference: 37313485 (https://mhra-gov.filecamp.com/s/d/dreEcrIeCwKIiJc6) 2025/006/002/601/030

Sectra: Sectra Core

DOC-LHEN-DMBC9R-1.0Description

MHRA reference: 37354032 (https://mhra-gov.filecamp.com/s/d/4GP0CNMOvz327cgT) 2025/010/014/601/020

Siemens: 3 Tesla MRI system

12 August 2025

FSN MR041/25/S

MRI system, full body

MHRA reference: 37328410 (https://mhra-gov.filecamp.com/s/d/UNP5RyQpHt3Yclnn) 2025/010/008/601/001

THOR Photomedicine: NovoTHOR and NovoTHOR XL

001FSCA25

Phototherapy unit, red light, line-powered

Model: S2188 and S2190

MHRA reference: 37332923 (https://mhra-gov.filecamp.com/s/d/cz3NPk4NUaixZp6K) 2025/008/012/601/067