Field Safety Notices (FSNs): 16/03/26 – 20/03/26

Manufacturers’ Field Safety Notices

Circulation

DL1 NHS Incidents and alerts Safety Officers

DL2 Local Authority Incidents and alerts Safety Officers

DL3 Specialist Liaison Group

DL4 Product Specialists

DL5 General list (internal)

DL7 General list (external)

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

1.     Product Recall: Tek Squad 5000 MAH Portable Power Bank (2511-0116)

2.     Product Safety Report: Labubu-Style Plush Toy with Pull Cord (2510-0159) updated

Section 2: medical devices 16/03/26 – 20/03/26

1. AusDiagnostics: Respiratory Pathogens 24 well 46100 MHRA reference: 38871547 2026/003/013/601/005
2. Clinical Innovations: Kiwi Omni Vacuum Delivery System 46092 Foetal vacuum extraction system cup, single-use Model: VAC-6000MTE MHRA reference: 38815266 2026/003/011/601/122
3. Diagnostic Grifols: Serascan Diana 3 46092 MHRA reference: 38819756 2026/003/013/601/018
4. Elekta: Leksell Vantage Arc System 46054 Stereotactic surgery system, neurological MHRA reference: 38774245 2026/003/010/601/069
5. GE Medical Systems: SIGNA Premier Ref 63006 MHRA reference: 38868186 2026/003/018/601/010
6. Immucor: Panocell-20 46037 Model: IMM0005020 MHRA reference: 38879726 2026/003/019/601/160
7. Medtronic: Sphere-9 catheter March 2026 FA1546 Model: AFR-00001 MHRA reference: 38871827 2026/003/006/601/106
8. PathoFinder: RealAccurate® Quadruplex Bordetella PCR Kit 46098 MHRA reference: 38879290 2026/003/019/601/065
9. Spacelabs: Xprezzon Bedside Monitor Ref 3010157426-08112025-001-C Single-patient physiologic monitoring system Model: 91393 MHRA reference: 38869445 2026/002/019/601/054
10. Stryker: Darco 7.0 Headless Screw 16×6 46082 MHRA reference: 38886954 2026/002/027/601/077

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)

NHSScotland Assure

NHS National Services Scotland

Tel: 0131 275 7575 | nss.iric@nhs.scot 

IRIC operates incident learning and prevention systems for health and care technologies (medical devices, IVDs, estates, facilities, social care equipment and PPE). Find out more in CEL43 (2009), explore our educational content on Turas Learn or visit our website to: report an incident, find our safety alerts, or watch our short Intro to IRIC video

We are NHS National Services Scotland. We offer a wide range of services and together we provide national solutions to improve the health and wellbeing of the people of Scotland. Find out more in our NSS Strategic Framework 2024-2026

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

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