Field Safety Notices (FSNs): 28/07/25 – 01/08/25

Manufacturers’ Field Safety Notices

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DL1 NHS Incidents and alerts Safety Officers

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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

1.     Product Safety Report: Hytek Electronic Tank Gauge Kit (Liquid Level Gauge) (2506-0116)

2.     OPSS issues stop warning for 17,000 heat pump tumble dryer owners

Section 2: medical devices 28/07/25 – 01/08/25

1. Cardiac Pacemakers, Inc: ENDOTAK RELIANCE 45862 Lead, defibrillator, implantable MHRA reference: 36322149   2025/007/021/601/095
2. Cook Endoscopy/Wilson Cook Medical: Instinct Plus Endoscopic Clipping Device 45868 GI endoscopic clip, long term, non-bioabsorbable MHRA reference: 36300400   2025/007/025/601/102
3. Dentsply Implants Manufacturing GmbH : IO FLO-S Kit A04A, A04B, A04S 45869 Dental implant suprastructure, temporary, reusable MHRA reference: 36330080   2025/007/014/601/075
4. GS Elektromedizinische Geräte G. Stemple GmbH: corpuls3, corpuls3 Touch 45855 Physiologic-monitoring defibrillation system Model: 04100, 04101, 04200, 04201, 04300, 04301 MHRA reference: 36342406    2025/007/031/601/030
5. Medical (Heartsine Technologies Ltd.) : HeartSine samaritan® PAD 350P/360P/450P/500P 45809 Model: HeartSine SAM 350P- HeartSine SAM 360P- HeartSine SAM 450P- HeartSine SAM 500P- HeartSine HDF3500 Omron AED MHRA reference: 36321341   2025/007/008/601/109
6. METASYSTEMS PROBES GmbH: XL TP53/17cen, XL BCL2 BA, XL MYC BA 45866 MHRA reference: 36306433   2025/007/028/601/023
7. Nipro Corporation: Surdial X & Surdial 55Plus 45866 HAEMODIALYSIS EQUIPMENT MHRA reference: 36318587   2025/007/029/601/058  MHRA reference: 36318587   2025/007/029/601/058

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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