Field Safety Notices: 20 to 24 October 2025
List of Field Safety Notices from 20 to 24 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 a list of FSNs published since January 2020
View FSNs since November 2014. FSNs before this date are on the National Archives website
Baxter Healthcare SA: EVO IQ Large Volume Pump
15th August 2025
Bedside infusion pump, single-channel
Model: ELVP001UKI
MHRA reference: 37397515 2024/011/028/601/018
MHRA reference: 37397515 2024/011/028/601/018 – Customer reply form
Bio-Rad: Genie Fast HIV ½
9th October 2025
HIV1/HIV2 antibody IVD, kit, (ICT), rapid
MHRA reference: 37398742
Cardinal Health 200, LLC: Kendall SCD™ 700 Sequential Compression System
22nd October 2025
Pneumatic Compression Equipment
MHRA reference: 37418709 2025/010/021/601/128
Cepheid AB : Xpert HIV-1 Viral Load XC
13th October 2025
MHRA reference: 37419965 2025/010/021/601/052
Cepheid AB : Xpert CT/NG
20th October 2025
MHRA reference: 37436381 2025/010/010/601/056
Datex-Ohmeda, Inc: Giraffe Omnibed Carestation CS1; Giraffe Omnibed
21st March 2025
Incubator, infant, stationary
MHRA reference: 37420686 2024/010/011/601/027
MHRA reference: 37438630 2024/010/011/601/027
(Both FSNs are different and each FSN requires attention.)
GE Ultrasound Korea, Ltd: LOGIQ P9 and P10
FMI 74084
Ultrasound System Imaging, General Purpose
MHRA reference: 37444100
HUMAN Gesellschaft für Biochemica und Diagnostica mbH: AUTOCAL
16th October 2025
Multiple-type clinical chemistry analyte profile I
MHRA reference: 37398566
MHRA reference: 37398566 – reply form
KANEKA Corporation: Senri ™ balloon dilatation catheter
9th October 2025
MHRA reference: 37397044 2025/010/006/601/017
LivaNova USA, Inc. : Symmetry™ VNS Therapy™ Generator
22nd October 2025
Model 8103
MHRA reference: 37444383 2025/010/023/601/001
Medical (Heartsine Technologies Ltd.): HeartSine samaritan Pad-Pak and Pediatric-Pak
06th October 2025
MHRA reference: 37396940 2025/009/023/601/053
Remote Diagnostic Technologies Ltd : Tempus Pro
9th October 2025
Transportable physiologic monitoring system
Model: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R
MHRA reference: 37411962 2025/004/017/601/037
SCHILLER AG : EASY PULSE
17th October 2025
Cardiac resuscitator, battery-powered
Model: 3.940409 (GTIN: 07613365001853) 3.940410 (GTIN: 07613365001679)
MHRA reference: 37400930
Shenzhen Mindray bio-medical electronics, ltd: V90 electronic vaporizer
13th October 2025
MHRA reference: 37398834
Synthes GmbH, Oberdorf : MatrixMIDFACE & MatrixMANDIBLE
15th October 2025
Craniofacial bone screw, non-bioabsorbable
Model: NA546-31-0000546-31-2000546-31-4000546-31-6000546-31-8000546-32-0000
MHRA reference: 37425126 2025/010/014/601/087