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Manufacturers’ Field Safety Notices
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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: Croydex Kentmere, Harrop, Simpson and Belham Mirrors ( 2508-0077)
Section 2: medical devices 25/08/25 – 29/08/25
- CareDx Pty Ltd: AlloSeq cfDNA 45890 Model: Refer to FSN MHRA reference: 36545854 2025/008/021/601/070
- Datascope Corp-Getinge: CARDIOSAVE IABP HYBRID AND RESCUE CONFIGURATIONS OT 577031 – FLUID INGRESS 45889 Cardiosave Intra-Aortic Balloon Pumps Model: Refer to FSN MHRA reference: 36545743 2025/008/022/601/115
- Fiab SpA: Defibrillation electrodes model F7987W 20.08.2025 FSN ref: 187 Disposable adhesive electrodes for external defibrillation Model/LOT: Refer to FSN MHRA reference: 36565517 2025/008/027/601/020
- GE HealthCare: Optima XR200amx, Optima XR220amx and Optima XR240amx – UPDATED FSN 45866 Ref. # 10964-C Update to FSN ref MHRA reference: 34176852 X-ray system, diagnostic, General-Purpose, Mobile MHRA reference: 36571165 2024/012/010/601/088
- Gyrus ACMI, Inc / Olympus: ViziShot 2 FLEX (19G) 13.08.2025 Endoscopic ultrasound-guided aspiration needle Model: Refer to FSN MHRA reference: 36558600 2025/008/008/601/010
- ICU Medical: CADD Medication Cassette Reservoir 28.08.2025 Infusion pump cassette Model: Refer to FSN MHRA reference: 36547888 2025/008/025/601/008
- IntersurgicaL Ltd: Various BVM Resuscitators 28.05.2025 BVM Resuscitators Model: Refer to FSN MHRA reference: 35876831 2025/005/019/601/023
- Jaeger Medical: VYNTUS products with SNIP/RHINO Option 45887 CRF#: 2020-036 Reprocessing instructions Model: Refer to FSN MHRA reference: 36524861
- Riverside Medical Packaging: Aseptic Medical Devices (AMD) Sterile Transfer Sets & Accessories 45889 FSN 2025-001 Model: Refer to FSN MHRA reference: 36548829 2025/008/022/601/033
- Siemens Healthcare: INNOVANCE VWF Ac 45809 Model: Refer to FSN MHRA reference: 36497358 2025/007/004/601/047
- Stryker: STRYKEFLOW2 45870 Recall Number: RA2025- 4025396 STRYKEFLOW2 WITH /without DISPOSABLE TIP Model: Refer to FSN MHRA reference: 36546104 2025/008/025/601/037
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
| Page summary | Change(s) made |
| n/a | n/a |
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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