Field Safety Notices (FSNs): 26/05/25 – 30/05/25

Manufacturers’ Field Safety Notices

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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.    Heat pump tumble dryers

2.     Product Recall: SIP Industrial Products Fireball ID78 23kW Diesel Infra-red Heater (2503-0026)

3.    Product Recall: LXINSHU Half Body Climbing Harnesses (2505-0149)

4.     Product Recall: George Baby 3-Pack Rompers with Zip sold by Asda (2505-0169)

5.     New posters promoting button battery safety

6.    Product Safety Report: Online Home Shop OHS Electric Over Blanket (5 Styles) (2504-0176)

7.    Product Recall: Brown Safety Trainers sold via TikTok (2505-0077)

8.    Product Recall: Aico Ei3014 Heat Detector (2504-0285)

9.    Product Recall: Landis + Gyr B2 and B3 Smart Meter Bridge (2504-0289)

Section 2: medical devices 26/05/25 – 30/05/25

1. Beckman Coulter: Access Erythropoietin (EPO) 45791 Description: Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay MHRA reference: 35717607 2025/005/026/601/049
2. Becton, Dickinson: BD FACS 7-Color Setup Beads 45811 Description: Optical instrument performance standard calibrator MHRA reference: 35754068 2025/005/029/601/034
3. Belmont Medical Technologies: Allon 45805 Description: Circulating-fluid whole- body heating/cooling syst MHRA reference: 35729211 2025/005/028/601/190
4. BioFire Diagnostics: BIOFIRE BCID2 Panel 45809 Description: Bloodstream infection-associates microorganism nuc Model: RFIT-ASY-0147 MHRA reference: 35753777   2025/005/029/601/016
5. Canon Medical Systems Corporation: Canon MR System MRT-1550/xx s/n 1A serial number 1.5T MR System 45803 Description: Full-body MRI system, superconducting magnet Model: Atlas, Titan, Orian, Elan, Galan, Centurian etc. MHRA reference: 35716914 2025/005/023/601/075
6. IdealMed: Ideal Ring Fixator 45776 Description: External Orthopaedic Fixation System, Reusable Model: Probably IM1600007 MHRA reference: 35753665 2025/005/029/601/023
7. implantcast GmbH: MUTARS proximal femur and MUTARS proximal femur revision 45803 Model: 009300013, MPFESTxx, MPFRSTxx, 57600011, 57600011N, 57691211, 59021211, 59021211N, 59031211, 59031211N, 57601116, 57601116N, 57691611, 59021611, 59021611N, 59031611, 59031611N, 57601120, 57601120N, 57692011, 59022011, 59022011N, 59032011, 59032011N, 57601320, 57601320N, 57692013, 59022013, 59022013N, 59032013, 59032013N, 57600512, 57600012 MHRA reference: 35716720 2025/005/026/601/053
8. Intersurgical: i-View Video Laryngoscope 45810 Description: Video intubation laryngoscope kit MHRA reference: 35729259 2025/005/028/601/134
9. MEDTRON AG: All consumables produced by MEDTRON AG 45797 MHRA reference: 35716719 2025/005/023/601/068
10. QuidelOrtho: VITROS 4600 Chemistry Systems and VITROS 5600 and XT 7600 Integrated Systems Reference: CL2025-111 Description: Multiple clinical chemistry analyser IVD lab MHRA reference: 35729152 2025/005/028/601/167

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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