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 . FSNs before this date are on the
Baxter Healthcare SA: EVO IQ Large Volume Pump
15th August 2025
Bedside infusion pump, single-channel
Model: ELVP001UKI
MHRA reference: Ìý 2024/011/028/601/018
MHRA reference: Ìý 2024/011/028/601/018 – Customer reply form
Bio-Rad: Genie Fast HIV ½
9th October 2025
HIV1/HIV2 antibody IVD, kit, (ICT), rapidÌý
MHRA reference: Ìý
Cardinal Health 200, LLC: Kendall SCDâ„¢ 700 Sequential Compression System
22nd October 2025
Pneumatic Compression Equipment
MHRA reference: ÌýÌý 2025/010/021/601/128
Cepheid AB : Xpert HIV-1 Viral Load XCÌý
13th October 2025
MHRA reference: ÌýÌý Ìý2025/010/021/601/052ÌýÌý
Cepheid ABÌý: Xpert CT/NG
20th October 2025
MHRA reference: Ìý 2025/010/010/601/056Ìý
Datex-Ohmeda, Inc: Giraffe Omnibed Carestation CS1; Giraffe Omnibed
21st March 2025
Incubator, infant, stationary
MHRA reference: Ìý 2024/010/011/601/027
MHRA reference: Ìý 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: ÌýÌý
HUMAN Gesellschaft für Biochemica und Diagnostica mbH: AUTOCAL
16th October 2025
Multiple-type clinical chemistry analyte profile I
MHRA reference:
MHRA reference: – reply form
KANEKA Corporation: Senri â„¢ balloon dilatation catheter
9th October 2025
MHRA reference: ÌýÌý Ìý2025/010/006/601/017
Medical (Heartsine Technologies Ltd.): HeartSine samaritan Pad-Pak and Pediatric-Pak
06th October 2025
MHRA reference: ÌýÌý 2025/009/023/601/053 Ìý
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: Ìý 2025/004/017/601/037ÌýÌý
SCHILLER AG : EASY PULSE
17th October 2025
Cardiac resuscitator, battery-powered
Model: 3.940409 (GTIN: 07613365001853) 3.940410 (GTIN: 07613365001679)
MHRA reference: Ìý
Shenzhen Mindray bio-medical electronics, ltd: V90 electronic vaporizer
13th October 2025
MHRA reference: 2025/010/015/601/005ÌýÌýÌý
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: Ìý 2025/010/014/601/087