Field Safety Notices (FSNs): 08/09/25 – 12/09/25

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.     Haier to restart heat pump tumble dryer safety repair programme

2.     Product Safety Report: Hisense Heat Pump Tumble Dryer (2508-0198)

3.     Product Safety Report: Louvolite Perfect Fit Roller and Vision Blinds Chain Tidy (2508-0141)

4.     Product Recall: Halfords Essentials Nyala R129 Car Seat (2509-0032)

Section 2: medical devices 08/09/25 – 12/09/25

1. Abiomed, Inc: Automated Impella Controller (AIC)  21st August 2025 Intracardiac circulatory assist axial-pump catheter Model: 0042-0000 MHRA reference: 36670459    2025/008/022/601/038
2. Beckman Coulter, Inc: CellMek SPS 3rd September 2025 AUTOSAMPLERS MHRA reference: 36679934    2025/009/001/601/022
3. Drive Medical GmbH: AeroWalk Rollator / Drive DeVilbiss 1st September 2025 Walking aid Model: 7202000X0 MHRA reference: 36650921   2025/008/019/601/057
4. EO Laboratories Ltd: Cooked Meat with Brain Heart Infusion Broth Overlay 4th September 2025 Enriched broth culture medium IVD MHRA reference: 36658088   2025/009/005/601/045
5. Maquet Cardiopulmonary GmbH: Heater Unit HU 35 11th September 2025 Heat exchanger, Heart-Lung bypass Model: 701072162, 701072163 MHRA reference: 36699824   2025/009/011/601/054
6. Maquet Cardiovascular, LLC: VASOVIEW HEMOPRO 2 45839 MHRA reference: 36696922   2025/003/011/601/068
7. MicroVention Europe SARL: RENZAN™ Peripheral Stent System 3rd September 2025 MHRA reference: 36689592   2025/009/010/601/031
8. Olympus Medical Systems Corporation : Flexible video bronchoscope, reusable 11th September 2025 Model: See attached Excel Spreadsheet MHRA reference: 36658074   2025/009/005/601/040
9. Philips Medical Systems Nederland BV: Allura Xper, Allura CV20. 3rd September 2025 Stationary angiographic x-ray system, digital Model: 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722015, 722020, 722022, 722023, 722025, 722026, 722027, 722028, 722029, 722031, 722033, 722035, 722038, 722039, 722058, 722059 MHRA reference: 36658087   2025/009/005/601/056

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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