Field Safety Notices (FSNs): 27/10/25 – 31/10/25

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.     Product Safety Report: ORTONES Wheelchair and Geriatric Arm Chair Lap Belt sold via Amazon (2510-0031)

2.     Product Safety Report: Petiyark Neoprene Swim Vest (2510-0107)

3.     Product Recall: Maxi Cosi Jay Plus Removable Tray (2510-0198)

Section 2: medical devices 27/10/25 – 31/10/25

1. Beckman Coulter: UniCel DxI 600 and 800 Analyzers 45931 MHRA reference: 37457734 2025/010/001/601/015
2. Breas Medical: Clearway 2 45958 In-exsufflator Model: 232000 MHRA reference: 37484961
3. Delcath Systems: CHEMOSAT 45943 Hemoperfusion Unit MHRA reference: 37478494 2025/010/009/601/040
4. Dieter Marquardt: VITUS-Fi Distal Fibula Nail 45936 nail, bone  MHRA reference: 37459667 2025/010/023/601/081
5. Egton Medical Information Systems Ltd trading as Optum: ePMA 45959 Pharmaceutical Reference Data Software MHRA reference: 37508274 2025/010/029/601/145
6. Immucor: PakPlus March 2025 FA-WKS-25-003 MHRA reference: 37496060 2025/010/029/601/122
7. Immucor: Factor VIII Antibody Screen March 2025 FA-WKS-25-004 Coagulation factor VIII IVD, kit, chromogenic Model: F8S MHRA reference: 37501132 2025/010/029/601/134
8. Inpeco: FlexLab X 45958 MHRA reference: 37507678 2025/010/030/601/056
9. Medtrade: CELOX PPH 45950 Model: FG08838281, FG08838171, FG08838291 and FG08838321 MHRA reference: 37498213 2025/010/028/601/074
10. Rocialle Healthcare: Specimen Container 30ml double wrapped 45876 MHRA reference: 37458768 2025/010/004/601/002
11. Siemens: Atellica CI Analyzer, Atellica IM Analyzer, ADVIA Centaur XP System, ADVIA Centaur XPT System, ADVIA Centaur CP System 45931 MHRA reference: 37478314 2025/004/015/601/086

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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