Field Safety Notices: 14 to 18 April 2025
Source: gov.uk (2025-04-25)

List of Field Safety Notices from 14 to 18 April 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/PkLTx2auMKHIEPY2)

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)

BioFire Diagnostics: BCID2 Panel

7 April 2025

Bloodstream infection-associates microorganism nuc

Model: RFIT-ASY-0147

MHRA reference: 35261289 (https://mhra-gov.filecamp.com/s/d/qrAmsczUcGYzmCsU) 2025/004/002/601/083

Cepheid: Xpert BCR/ABL Ultra & Xpert BCR/ABL Ultra p190

3 April 2025

MHRA reference: 35341668 (https://mhra-gov.filecamp.com/s/d/HjFcdy0dWTeGAcq8) 2025/004/016/601/100

Cook Incorporated: Tornado® Embolization Microcoil™

17 April 2025

Non-neurovascular embolization coil

Model: MWCE-18S-3/2-TORNADO and MWCE-18S-4/2-TORNADO

MHRA reference: 35332982 (https://mhra-gov.filecamp.com/s/d/fSWCPYqpU4dPjDLp) 2025/004/015/601/112

GE Healthcare Finland Oy: Centricity High Acuity Anesthesia / Critical Care

FMI 38015

Patient health record information system

MHRA reference: 35334427 (https://mhra-gov.filecamp.com/s/d/lwls7xIK50HXjHne) 2025/004/015/601/079

Green Power Trading: FASTEST

8 April 2025

Powered Mobility Scooter

MHRA reference: 35332728 (https://mhra-gov.filecamp.com/s/d/0CcDBdfJMRagRLBW) 2025/004/015/601/025 - Updated FSN

MHRA reference: 35332728 (https://mhra-gov.filecamp.com/s/d/4JnCaR0jroXycCp8) 2025/004/015/601/025 – Updated Customer Bulletin

JJGC INDÚSTRIA E COMÉRCIO DE MATERIAIS DENTÁRIOS S.A: GM Helix Implant

16 April 2025

Screw Endosteal Dental

Model: GM Helix Acqua Implant,Ti,4.0X11.5

MHRA reference: 35369434 (https://mhra-gov.filecamp.com/s/d/tJxTG1WqNpMtfTFm) 2025/004/016/601/114

MHRA reference: 35369434 (https://mhra-gov.filecamp.com/s/d/7LOqLQlJjpytB7w7) 2025/004/016/601/114 – Customer reply form

Leica Biosystems Melbourne Pty Ltd: HistoCore PELORIS 3

14 April 2025

Tissue processor IVD, automated

Model: 45.0001

MHRA reference: 35303791 (https://mhra-gov.filecamp.com/s/d/ll6UqWihFNaSrYge) 2025/004/013/601/007

Normand-Info SASU: REMISOL Advance

1 April 2025

See Section 8

MHRA reference: 35319352 (https://mhra-gov.filecamp.com/s/d/eE9rjZiaGlHyocCO) 2025/004/014/601/098

MHRA reference: 35319352 (https://mhra-gov.filecamp.com/s/d/k3IHOZePzSMwE0tc) 2025/004/014/601/098 - Vigilance response form

Philips Medizin Systeme Böblingen GmbH: Microstream Advance, VitaLine, FilterLine

FSCA-2025-CC-HPM-011

Model: 989803204511 989803204321 989803204301 989803204331 989803204521 989803204531 989803204311 989803204341 989803159571 989803159581 989803160241 989803160251 989803160261 989803182921 989803182931 989803105531 989803105541 989803105561

MHRA reference: 35303765 (https://mhra-gov.filecamp.com/s/d/AJigbLaz1YLWcW5b) 2025/004/011/601/011 - FSN

MHRA reference: 35303765 (https://mhra-gov.filecamp.com/s/d/PeQZLGpCxKZj0T9z) 2025/004/011/601/011 - Letter

Philips: IntelliSpace Cardiovascular

7 April 2025

MHRA reference: 35304287 (https://mhra-gov.filecamp.com/s/d/k8frDElZ9YgWczez) 2025/004/011/601/007

MHRA reference: 35304287 (https://mhra-gov.filecamp.com/s/d/SoTZIdtunusXvUZg) 2025/004/011/601/007 – Letter and Response form

Remote Diagnostic Technologies Ltd: Tempus Pro

10 April 2025

Transportable physiologic monitoring system

Model: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R

MHRA reference: 35369193 (https://mhra-gov.filecamp.com/s/d/KuqepnL9wpUoyYL0) 2025/004/017/601/037

Siemens Healthcare Diagnostics Inc: See Comments

April 2025

See Comments

MHRA reference: 35330846 (https://mhra-gov.filecamp.com/s/d/wV0LgiqqH5fuPCPq) 2025/004/015/601/086

Togetherall Ltd: Togetherall

19 March 2025

Model: Not applicable

MHRA reference: 35367803 (https://mhra-gov.filecamp.com/s/d/Hz0sHYtodlgUau1B) 2025/004/xx-xxxx-xxxx – Customer reply form

MHRA reference: 35367803 (https://mhra-gov.filecamp.com/s/d/cRLZC2iaE30MvIZK) 2025/004/xx-xxxx-xxxx

Welch Allyn, Inc: See Comments “Section 8”

15 April 2025

See Comments “Section 8”

MHRA reference: 35334910 (https://mhra-gov.filecamp.com/s/d/fBIG84moJM0XXt2h) 2025/004/015/601/058

MHRA reference: 35334910 (https://mhra-gov.filecamp.com/s/d/lCDolcjIhnWFgwfU) 2025/004/015/601/058 - Attachment A