Field Safety Notices: 13 to 17 October 2025
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 . FSNs before this date are on the
Abbott: CentriMag Blood Pump
October 2025 FA-Q325-HF-2
Cardiopulmonary bypass system centrifugal pump
Model: 201-90010, CMAEK01
MHRA reference: 2025/010/015/601/030
Abbott: HeartMate II and HeartMate3 System Controllers
October 2025
Heart Ventricle Prosthesis
Model: 106017, 106524INT, 106531INT, 106531LF2
MHRA reference: 2025/010/015/601/020
GE Medical Systems: CARESCAPE Central Station
FMI 36167
Centralized Patient Monitor
MHRA reference: 2025/009/026/601/086
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: 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: 2025/010/013/601/015
Implant Restorations: G7 Acetabular System
13 October 2025
Non-constrained polyethylene acetabular liner
Model: 110031012; 110031013
MHRA reference: 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:
Masimo: RAd-G Pulse Oximeter
25 August 2025
Pulse oximeter
MHRA reference: 2024/003/027/601/025
Osatu S.Coop: REANIBEX300, REANIBEX500/BEXEN CARDIO/OSATU S.COOP
06 October 2025
47910-External Defibrillator;17882-Monitor Defi.
MHRA reference:
Recordati: Caphosol
24 June 2025
artificial saliva
MHRA reference: 2025/006/002/601/030
Sectra: Sectra Core
DOC-LHEN-DMBC9R-1.0Description
MHRA reference: 2025/010/014/601/020
Siemens: 3 Tesla MRI system
12 August 2025
FSN MR041/25/S
MRI system, full body
MHRA reference: 2025/010/008/601/001
THOR Photomedicine: NovoTHOR and NovoTHOR XL
001FSCA25
Phototherapy unit, red light, line-powered
Model: S2188 and S2190
MHRA reference: 2025/008/012/601/067