Field Safety Notices: 7 to 11 July 2025
Source: gov.uk (2025-07-21)

List of Field Safety Notices from 7 to 11 July 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/1STQsAnIdHW4O6ta)

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 SA : Sharesource Adequest

July 2025

Nephrology information system software

MHRA reference: 36119293 (https://mhra-gov.filecamp.com/s/d/l7JqG1oJAp23Wtbc) 2025/007/008/601/027

Boston Scientific Corporation : Carotid WALLSTENT™ Monorail Endoprosthesis

7 July 2025

MHRA reference: 36081820 (https://mhra-gov.filecamp.com/s/d/I5ojSzsTAHGZw7rf) 2025/007/007/601/066

Boston Scientific Neuromodulation Corporation: SureTek Burr Hole Cover Kit

9 July 2025

Deep brain electrical stimulation system

MHRA reference: 36081583 (https://mhra-gov.filecamp.com/s/d/TSXvh5ayWcAN7yI6) 2025/007/007/601/085

Microgenics Corporation : CEDIA Amphetamine Oral Fluid Testing (OFT) Assay

25 June 2025

MHRA reference: 36101731 (https://mhra-gov.filecamp.com/s/d/KbcAXFvUqzrbSyGT) 2025/007/001/601/125

Osstell AB : Osstell SmartPeg

30 June 2025

Type 101, 102, 103 & 104

MHRA reference: 36110623 (https://mhra-gov.filecamp.com/s/d/wCBiPZf1AAU2ZJ1U) 2025/007/009/601/089

Perouse Medical : POLYPERF

9 July 2025

Needle, subcutaneous injection/infusion port

MHRA reference: 36110499 (https://mhra-gov.filecamp.com/s/d/l6oqpCOtW00zctYu) 2025/007/009/601/036

MHRA reference: 36110499 (https://mhra-gov.filecamp.com/s/d/P8HmpeNhaK6tPlLN) 2025/007/009/601/036 - Customer reply form

Philips Medical Systems Nederland B.V: See Model number

30 June 2025

Magnetic Resonance Imaging (MRI) unit

Model: Achieva 3.0T - 781177, 781277, 781278, 781344, 781345, Achieva XR - 781153, 781253 Evolution upgrade 1.5T - 782116, 782148 Evolution upgrade 3.0T - 782117, 782143 Ingenia 1.5T - 781315, 781341, 781396, 782101, 782115, 782140 Ingenia 1.5T S - 781347 Ingenia 3.0T - 781342, 781377, 782103 Ingenia 3.0T CX - 781271, 782105 Ingenia Ambition S - 781359, 782108, 782133, 782139 Ingenia Ambition X - 781356, 782109, 782138 Ingenia Elition S - 781357, 782106, 782137, 782150 Ingenia Elition X - 781358, 782107, 782119, 782136, 782151 Intera 3.0T Quasar Dual - 781150 MR 5300 - 782110, 782135, 782152 MR xx-xxxx-xxxx, 782153 SmartPath to dStream for 3.0T - 782145, SmartPath to dStream for XR and 3.0T - 781270, 782113, 782129 SmartPath to Ingenia Elition X - 782118, 782144 Upgrade to MR xx-xxxx-xxxx

MHRA reference: 36036261 (https://mhra-gov.filecamp.com/s/d/3ckAQ4EI2YsYIL7k) 2025/007/001/601/098

Stryker : UNIVERSAL JOINT SCREWDRIVER

March 2025

MHRA reference: 36040370 (https://mhra-gov.filecamp.com/s/d/LGuuKtbxRG3YIy4o) 2025/004/003/601/030