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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
None
Section 2: medical devices 31/03/25 – 04/04/25
- Alchimia S.R.L: GOT multi 13th February 2025 Vitreous humour replacement medium, post-operative MHRA reference: 35236225 2025/004/003/601/027
- Bausch + Lomb: enVista Aspire IOL, enVista Aspire Toric IOL 31st March 2025 Lens, intraocular, posterior chamber MHRA reference: 35209472 2025/004/001/601/026
- Beckman Coulter: DxI 9000 Access Immunoassay Analyzer 25th March 2025 See section 8 MHRA reference: 35198466 2025/003/031/601/010 MHRA reference: 35198466 2025/003/031/601/010 – Vigilance response form
- BioFire Diagnostics: BCID2 Panel 7th April 2025 Bloodstream infection-associates microorganism nuc Model: RFIT-ASY-0147 MHRA reference: 35219490 2025/004/002/601/083
- Datex-Ohmeda: Carestation 600 and 750 Series FMI 34142 Anaesthesia Workstation, general-purpose MHRA reference: 35202661 2025/003/031/601/055
- GE Healthcare: Please see section 8 Comments 10th March 2025 MHRA reference: 35193952 2025/003/005/601/069
- Spineart SA: Transforaminal lumbar cage JULIET®Ti 25th March 2025 MHRA reference: 35219893 2025/004/001/601/020
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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