Field Safety Notices (FSNs): 27/04/26 – 01/05/26

Manufacturers’ Field Safety Notices

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DL1 NHS Incidents and alerts Safety Officers

DL2 Local Authority Incidents and alerts Safety Officers

DL3 Specialist Liaison Group

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DL5 General list (internal)

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Outlook tags     IRICSW$i0 (safety alert – general), IRICSW$i5 (field safety notices)

This message is sent to share information on manufacturers’ field safety notices (FSNs) which have been brought to our attention. Manufacturers have a legal duty to distribute these notices to affected customers.

This message does not affect the manufacturer’s FSN distribution, but it provides a reference source to check against.

You should always contact your supplier or the manufacturer if you are affected by a field safety notice listed below but have not received it from them. This will help ensure that you are not also missed from future FSN distributions. Note that field safety notices will only be listed in the sections below if we have been made aware of them.

Section 1 below lists selected FSNs and other relevant safety updates for estates, facilities or general products which have been brought to our attention through various sources including Office for Product Safety and Standards (OPSS). Section 2 lists FSNs for medical devices brought to our attention specifically by Medicines and Healthcare products Regulatory Agency (MHRA).

Section 1: estates, facilities or general products

None

Section 2: medical devices 27/04/26 – 01/05/26

1. Bolton Medical, Inc. (operating as Terumo Aortic): RelayPro Thoracic Stent-Graft System FSN2026-002 Thoracic Aortic Stent-Graft Model: Refer to FSN MHRA reference: 39395801   2026/004/030/601/065
2. Breas Medical AB: Firmware Version 3.2.1/4.2.1/7.2.1 for Vivo 45 LS (non-US), and Nippy 4+ (CAPA-385) 46129 FSN ref: CAPA-385, 2026/004/017/601/088 Vivo 45 LS (non-US) (REF 230000) and Nippy 4+ (REF 231000) Ventilators Model: Refer to FSN MHRA reference: 39357337   2026/004/017/601/088
3. Caesarea Medical Electronics: BD BodyGuard T Syringe Pump 46132 Ambulatory Syringe Pump MHRA reference: 39279394 2026/004/002/601/129
4. Elekta/Nucletron: Intra uterine tube 46113 Cervical/intrauterine brachytherapy system applicator, remote-afterloading Model: 1053958 (MDD) (10040048 MDR) MHRA reference: 39283826   2026/003/026/601/060
5. Exmoor Plastics Ltd.: Aural Vent Tubes (PTFE) 46134 FSN Ref: HHE-2026-003 Exmoor Plastics Limited Aural Ventilation Tubes Tympanostomy tube Model: Refer to FSN MHRA reference: 39396376   2026/004/014/601/096
6. Limacorporate: PHYSICA ZUK ARTICULAR SURFACES 46126 Model: 5842-26-14; 5842-23-12 MHRA reference: 39236087 2026/004/014/601/084
7. Medtronic: SynchroMed April 2026 FA1536 Model: A810 MHRA reference: 9279627 2026/003/010/601/082
8. Medtronic: Gundry or DLP Retrograde April 2026 FA1554 Model: 94115T, 94113T 94215T, 94965, 94913, 94725, 94915, 94965, 94913L MHRA reference: 39293654 2026/003/018/601/099
9. MicroVention: BOBBY Balloon Guide Catheter 46142 MHRA reference: 39311043 2026/004/028/601/122
10. Olympus: HF-cable, bipolar 46098 Cables/Leads, Electrosurgical Unit Model: WA00014A MHRA reference: 39293085 2026/003/010/601/039
11. Philips: Azurion 24 April 2026 ref 2024-IGT-BST-023 Interventional Fluoroscopic X-Ray System MHRA reference: 39292632 2026/004/027/601/019
12. Philips: Allura and Azurion systems 24 April 2026 ref 2025-IGT-BST-020 Stationary angiographic x-ray system, digital Model: 722001, 722002, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722015, 722016, 722018, 722021, 722023, 722025, 722026, 722027, 722028, 722029, 722030, 722035, 722038, 722039, 722043, 722044, 722058, 722059, 722063, 722064, 722067, 722068, 722078, 722079, 722223, 722224, 722225, 722226, 722228, 722400 MHRA reference: 39296019 2026/004/027/601/056
13. Philips: Zenition 10 and Zenition 30 28 April 2026 ref 2024-IGT-PUN-009 Interventional Fluoroscopic X-Ray System Model: 718401 and 718076 MHRA reference: 39331121 2026/004/029/601/116
14. Schuchmann: Madita-fun integrative therapy chair 46114 MHRA reference: 39295859 2026/004/022/601/063

The above list of FSNs for medical devices is copied from the relevant MHRA web page. If you wish to browse or search for FSNs on the MHRA website, please click here. 

Section 3: updates and changes to previously published medical device FSNs

Adverse Incidents

Incidents and near-misses should always be reported to local incident management systems (often referred to as Datix, Ullyses, SHE, etc.). However, IRIC also needs to be informed about incidents and near-misses when they involve:

• Medical devices, e.g. infusion pump, central line, hoist, care bed, x-ray machine, ventilator
• In vitro diagnostic devices or IVDs, e.g. blood analyser, reagent, SARS-CoV-2 test kit
• Estates and facilities, e.g. electrical installations, window restrictors, nurse call systems
• Social care equipment, e.g. mobile wheeled commode, powered rise and recline chair
• Personal protective equipment or PPE, e.g. visors, FFP3 respirators, aprons

We need incident reports so we can work with manufacturers and our partners to stop the same thing happening again. Health and care professionals can also report safety concerns about equipment and devices when an incident or near-miss has yet to occur. Information about how to report an incident to IRIC can be found here: https://www.nss.nhs.scot/health-facilities/incidents-and-alerts/report-an-incident/  

Kind regards

Incident Reporting & Investigation Centre (IRIC)

Public Services Delivery Scotland

Gyle Square | 1 South Gyle Crescent

Edinburgh | EH12 9EB

e: nss.iric@nhs.scot

m: 0131 275 7575

publicservicesdelivery.scot

FAC406-212, 8B(i), Rev 7

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