Field Safety Notices: 4 to 8 August 2025
List of Field Safety Notices from 4 to 8 August 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: PrisMax Systems and TherMax Blood Warmer Units
1 August 2025
FA Number: FAV-2025-005
Model: 955515, 955725, 955558
MHRA reference: 36372260 2025/007/029/601/054
BD Switzerland: BD Alaris™ Plus and Alaris™ neXus Syringe Pumps
30 July 2025
Syringe pump
Model: Refer to FSN
MHRA reference: 36368613 2025/007/025/601/092
CareDx Pty Ltd: AlloSeq cfDNA Software
7 August 2025
Cell-free DNA analysis interpretive software IVD
Model: IFU091_AlloSeq cfDNA Software IFU – CE
MHRA reference: 36399138 2025/008/007/601/031
Fresenius Kabi: Agilia VP MC WIFI
28 July 2025
Ref: ECMD202511 version 01
Product code: Z019730
MHRA reference: 36372133 2025/007/021/601/054
Haemoband Surgical Ltd: HB-SleeveLUX Proctoscope
1 August 2025
Ref: FSN-2025-01
Shelf-life extension
Affected batches: Lot PS2400000
MHRA reference: 36359166 2025/008/001/601/098 – Acknowledgement form
MHRA reference: 36359166 2025/008/001/601/098 - FSN
Max Mobility LLC: SpeedControl Dial utilized with SmartDrive MX2+ Power Assist Device
28 July 2025
Ref. FSCA CAPA 25-007
Manual wheelchair, power assist unit
Model: Refer to FSN
MHRA reference: 36354122 FSCA077-2025
Philips: Allura Xper systems
31 July 2025
Philips Reference: 2024-IGT-BST-014
Stationary angiographic x-ray system, digital
Model: Refer to FSN
MHRA reference: 36371739 2025/008/004/601/016
Philips Medical Systems: Pinnacle³ Radiation Therapy Planning System
August 2025
Philips Reference # 2025-EI-TPS-002
Radiation therapy software
Model: Refer to FSN
MHRA reference: 36381204
RaySearch Laboratories AB: RayStation/RayPlan
Medical Device Correction #161525
Various Radiotherapy Instrument – Software
Model: Refer to FSN
MHRA reference: 36401149 2025/008/007/601/052
SCHILLER AG: ARGUS PB-3000
8 August 2025
FSCA Ref: SAGQI-2335
Vital Signs Monitoring Instruments
Model: Refer to FSN
MHRA reference: 36402609 2025/008/007/601/060
Tracoe medical GmbH: Tracoe Vario Tracheostomy Tube REF 470-08
25 July 2025
Cannula
Model: Refer to FSN
MHRA reference: 36398862 2025/008/001/601/020
Vygon (UK) Ltd: Easymoov6 Enteral Feeding Pump
1 July 2025
FSN Ref: 2507/51788/00 - PM6/SS14/FSN
Enteral feeding pump
Model: 0VEPM6G02
MHRA reference: 36371973 2025/007/002/601/101
Welland Medical Ltd: Aura
4 August 2025
FSN Ref: 2025-07-29/3209
Ostomy pouch
Batches: VM07083
Model: MHDM513-30-GB1
MHRA reference: 36391381 2025/007/029/601/053 - User letter
MHRA reference: 36391381 2025/007/029/601/053 - Wholesaler letter