Field Safety Notices: 10 to 14 November 2025
List of Field Safety Notices from 10 to 14 November 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 a list of FSNs published since January 2020
View FSNs since November 2014. FSNs before this date are on the National Archives website
Abiomed: Automated Impella Controller (AIC)
10 October 2025
Intracardiac circulatory assist axial-pump cath
Model: 0042-0040; 0042-0010; 0042-0000
MHRA reference: 37639152 2025/010/010/601/082
BK Medical ApS: Ultrasound system type 2300, 1300, 1202
Ref. # 87013
MHRA reference: 37583397 2025/011/007/601/085
Datascope: Cardiosave Intra-Aortic Balloon Pumps
October 2025
Circulatory assist system, intra-aortic balloon
Model: 0998-XX-0800-XX; 0998-UC-0800-XX
MHRA reference: 37613263 2025/011/011/601/124
Drägerwerk: Vapor 2000 and Vapor 3000
November 2025
Anesthesia Unit Vaporizers
Model: M35054 and M36500
MHRA reference: 37607072 2025/011/010/601/011
Intuitive Surgical: da Vinci X, Xi
10 November 2025
Robotic Surgical System
Model: IS4000 Surgical System; IS4200 Surgical System
MHRA reference: 37723223 2025/011/010/601/050
Kerr Italia: K-Flex, Triple-Flex, K-Files, Hedstrom, Reamers
07 November 2025
Reamers (hand-held); File (hand-held), resp.
MHRA reference: 37580385 2025/011/007/601/129
Philips Ultrasound: Lumify Diagnostic Ultrasound system
31 October 2025
Ultrasound system, Imaging, General Purpose
MHRA reference: 37577281 2025/011/004/601/095
Pos-T-Vac: AVP-1000 Complete System
12 November 2025
Device for Urogenital system
MHRA reference: 37653674 2025/011/013/601/076
Shenzhen Mindray bio-medical electronics: Central Monitoring System
13 November 2025
Model: BeneVision / HYPERVISOR X
MHRA reference: 37651669 2025/011/013/601/018