Field Safety Notices: 21 to 25 September 2026
List of Field Safety Notices from 21 to 25 September 2026.
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
Becton Dickinson: BD Phoenix CPO Detect 6-well panel
25 August 2025
MHRA reference: 40883311 2026/008/018/601/095
CX Engineering: Electric table HE Spectralis BW 110-230V
04 September 2026
MHRA reference: 40882641 2026/009/014/601/039
F.H INDUSTRIE: CALCANAIL THREADED CANULATED SCREW D5
September 2026
MHRA reference: 40884402 2026/009/022/601/105
Gyrus: Olympus POWERSEAL 5-mm diameter x 23-cm long Curve
18 August 2026
Endoscopic electrosurgical handpiece/electrode
Model: PS-523CJDA
MHRA reference: 40915918 2026/008/012/601/106
Gyrus: BiCOAG Hemostasis Probe
19 August 2026
Endoscopic electrosurgical electrode, bipolar
Model: CD-B610LA,CD-B612LA,CD-B620LA,CD-B622LA
MHRA reference: 40885977 2026/008/012/601/046
Inspire Medical Systems: II Model 3024; lV Model 3028
Ref QP-00019
Implantable Pulse Generator
Model: 3024; 3028
MHRA reference: 40875688 2026/009/018/601/058
Intelerad: IntelePACS
15 September 2026
Radiological PACS software
MHRA reference: 40915709 2026/009/024/601/146
Intervascular SAS: Intergard Synergy & Intergard Standard
20 August 2026
Model: IGK0008-40, IGK0008RS15-40SG, IGK0008RS15SG, IGK0008RS20SG, IGK0008RS30SG, IGK0008RS45SG, IGK0008RS60SG, IGKAX0808RS45/20SG, IGKAX0808RS45/30SG
MHRA reference: 40820981 2026/009/003/601/128
Medtronic: InterStim SureScan MRI Lead & Percutaneous Extens
September 2026 Ref FA00001
Model: 978A1, 978B1, 3560022, 3560030
MHRA reference: 40822960 2026/008/028/601/097
Medtronic: OmniaSecure MRI SureScan 3930M Lead
September 2026 Ref FA00006
Model: 3930M
MHRA reference: 40900232 2026/009/011/601/033
Permobil: M5 Corpus
08 July 2026
Electric-motor-driven wheelchair, occupant-control
Model: M5
MHRA reference: 40863216 2026/007/020/601/071
Philips: BlueSeal SE: 782185 BlueSeal XE: 782192 Evolution upgrade 1.5T: 782116, 782148, 782166, 782201 Evolution upgrade 3.0T: 782117, 782143, 782162 Ingenia 1.5T: 781315, 781341, 781396, 782115, 782140 Ingenia 1.5T CX: 781262 Ingenia 1.5T S: 781347 Ingenia 3.0T: 781342, 781377, 782103 Ingenia 3.0T CX: 781271 Ingenia Ambition S: 781359, 782108, 782139, 782159, 782194 Ingenia Ambition X: 781356, 782109, 782138, 782160, 782195 Ingenia Elition S: 781357, 782106, 782137, 782157, 782180 Ingenia Elition X: 781358, 782107, 782119, 782136, 782151, 782158, 782181, 782198 MR 5300 782110, 782152, 782156, 782196 MR 7700 782120, 782153, 782155, 782179, 782199 SmartPath to dStream for 1.5T: 781260, 782112, 782146, 782165 SmartPath to dStream for 3.0T: 782145, 782164 SmartPath to dStream for XR and 3.0T: 781270, 782113, 782129 SmartPath to Ingenia Elition X: 782118, 782144, 782163 SmartPath to MR 7700: 782178, 782207 Upgrade dStream: 782127 Upgrade to MR 7700: 782130
September 2026
Magnetic Resonance Imaging (MRI) unit
MHRA reference: 40913437 2026/009/001/601/156
Rayner Intraocular Lenses: RayOne
23 September 2026
Lens, Intraocular, Posterior Chamber
MHRA reference: 40897441 2026/009/010/601/080
Schiller: FRED easy
September 2026
Defibrillator
Model: Battery for FRED easy
MHRA reference: 40918509 2026/009/025/601/013
Shockwave Medical: Reducer
10 September 2026
Vascular and Cardiac Prostheses – Other
Model: RED-001
MHRA reference: 40911343 2026/009/009/601/003