Field Safety Notices (FSNs): 10/11/25 – 14/11/25

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.     Emerging technologies in the field of button battery safety

2.     Product Recall: Tefal X-Force Stick Vacuum Cleaner (2511-0016)

3.     Product Recall: Marks and Spencer Stripe 2.5 Tog Baby Sleepbag (2511-0077)

4.     Product Safety Report: THISS (SZYDZS) Technology Co Ltd Charger sold via eBay (2511-0070)

5.     Product Safety Report: Fitbit Sense and Versa 3 Smart Watches (2509-0315)

6.     Product Safety Report: Google Pixel 4a Smartphone (2509-0316)

7.     Product Safety Report: Google Pixel 6a Smartphones (2509-0317)

Section 2: medical devices 10/11/25 – 14/11/25

1. Abiomed: Automated Impella Controller (AIC) 45940 Intracardiac circulatory assist axial-pump cath Model: 0042-0040; 0042-0010; 0042-0000 MHRA reference: 37639152 2025/010/010/601/082
2. BK Medical ApS: Ultrasound system type 2300, 1300, 1202 Ref. # 87013 MHRA reference: 37583397 2025/011/007/601/085
3. Datascope: Cardiosave Intra-Aortic Balloon Pumps 45931 Circulatory assist system, intra-aortic balloon Model: 0998-XX-0800-XX; 0998-UC-0800-XX MHRA reference: 37613263 2025/011/011/601/124
4. Drägerwerk: Vapor 2000 and Vapor 3000 45962 Anesthesia Unit Vaporizers Model: M35054 and M36500 MHRA reference: 37607072 2025/011/010/601/011
5. Kerr Italia: K-Flex, Triple-Flex, K-Files, Hedstrom, Reamers 45968 Reamers (hand-held); File (hand-held), resp. MHRA reference: 37580385 2025/011/007/601/129
6. Philips Ultrasound: Lumify Diagnostic Ultrasound system 45961 Ultrasound system, Imaging, General Purpose MHRA reference: 37577281 2025/011/004/601/095
7. Pos-T-Vac: AVP-1000 Complete System 45973 Device for Urogenital system MHRA reference: 37653674 2025/011/013/601/076
8. Shenzhen Mindray bio-medical electronics: Central Monitoring System 45974 Model: BeneVision / HYPERVISOR X MHRA reference: 37651669 2025/011/013/601/018

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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