Field Safety Notices: 4 to 8 August 2025
Source: gov.uk (2025-08-12)

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 the latest FSNs (https://mhra-gov.filecamp.com/s/o/o5R8ybmlCd4NQxaI)

View a list of FSNs published since January 2020 (https://mhra-gov.filecamp.com/s/9g5cLjjFatXruS5U/d)

View FSNs since November 2014 (https://mhra-gov.filecamp.com/s/ZOxdOzRzP22RziUW/fo). FSNs before this date are on the National Archives website (https://webarchive.nationalarchives.gov.uk/*/http:/www.mhra.gov.uk/index.htm)

Baxter Healthcare: PrisMax Systems and TherMax Blood Warmer Units

1 August 2025

FA Number: FAV-2025-005

Model: 955515, 955725, 955558

MHRA reference: 36372260 (https://mhra-gov.filecamp.com/s/d/YdykYNXAQxpMBSQy) 2025/007/xx-xxxx-xxxx

BD Switzerland: BD Alaris™ Plus and Alaris™ neXus Syringe Pumps

30 July 2025

Syringe pump

Model: Refer to FSN

MHRA reference: 36368613 (https://mhra-gov.filecamp.com/s/d/ad7OPumuJPYzCw9G) 2025/007/xx-xxxx-xxxx

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 (https://mhra-gov.filecamp.com/s/d/XUnCXrt7ANOollmN) 2025/008/007/601/031

Fresenius Kabi: Agilia VP MC WIFI

28 July 2025

Ref: ECMD202511 version 01

Product code: Z019730

MHRA reference: 36372133 (https://mhra-gov.filecamp.com/s/d/tMzCDVhPxb5enBGb) 2025/007/xx-xxxx-xxxx

Haemoband Surgical Ltd: HB-SleeveLUX Proctoscope

1 August 2025

Ref: FSN-2025-01

Shelf-life extension

Affected batches: Lot PS2400000

MHRA reference: 36359166 (https://mhra-gov.filecamp.com/s/d/dBc7YAkbGguXXAQZ) 2025/008/001/601/098 – Acknowledgement form

MHRA reference: 36359166 (https://mhra-gov.filecamp.com/s/d/J9RVCv2uEMgdfdJt) 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 (https://mhra-gov.filecamp.com/s/d/uQ7TE48IzevL1LrD) 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 (https://mhra-gov.filecamp.com/s/d/c4aZFRLbDi1nNbQE) 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 (https://mhra-gov.filecamp.com/s/d/J7shS0vPobTuzErD)

RaySearch Laboratories AB: RayStation/RayPlan

Medical Device Correction #161525

Various Radiotherapy Instrument – Software

Model: Refer to FSN

MHRA reference: 36401149 (https://mhra-gov.filecamp.com/s/d/kM91Tnpjis6D4tw3) 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 (https://mhra-gov.filecamp.com/s/d/eIuKw2RLy2IBr5ip) 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 (https://mhra-gov.filecamp.com/s/d/asle4zIMKzbV99VO) 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 (https://mhra-gov.filecamp.com/s/d/obkGkKQMeetmBIAp) 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 (https://mhra-gov.filecamp.com/s/d/B393Tz6iuF3KK9ql) 2025/007/xx-xxxx-xxxx - User letter

MHRA reference: 36391381 (https://mhra-gov.filecamp.com/s/d/mYB1xDFJwQwR5ZZG) 2025/007/xx-xxxx-xxxx - Wholesaler letter