Field Safety Notices: 7 to 11 July 2025
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 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 SA : Sharesource Adequest
July 2025
Nephrology information system software
MHRA reference: 36119293 2025/007/008/601/027
Boston Scientific Corporation : Carotid WALLSTENT™ Monorail Endoprosthesis
7 July 2025
MHRA reference: 36081820 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 2025/007/007/601/085
Microgenics Corporation : CEDIA Amphetamine Oral Fluid Testing (OFT) Assay
25 June 2025
MHRA reference: 36101731 2025/007/001/601/125
Osstell AB : Osstell SmartPeg
30 June 2025
Type 101, 102, 103 & 104
MHRA reference: 36110623 2025/007/009/601/089
Perouse Medical : POLYPERF
9 July 2025
Needle, subcutaneous injection/infusion port
MHRA reference: 36110499 2025/007/009/601/036
MHRA reference: 36110499 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 7700 - 782120, 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 7700 - 782130
MHRA reference: 36036261 2025/007/001/601/098
Stryker : UNIVERSAL JOINT SCREWDRIVER
March 2025
MHRA reference: 36040370 2025/004/003/601/030