Field Safety Notices (FSNs): 03/02/25 – 07/02/25

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.     Product Recall: Lexmark Industrial Laser Printer (2501-0202)

Section 2: medical devices 03/02/25 – 07/02/25

1. Allurion: Allurion Device / Elipse Gastric Balloon System 45679 Balloon, gastric, appetite-suppressing Model: 10D MHRA reference: 34605771   2025/001/031/601/011
2. Baxter : EXTENDED LIFE PD TRANSFER SET, MINICAP EXTEND LIFE 45588 Tubing set, peritoneal dialysis MHRA reference: 34640703   2024/010/022/601/043 – Letter
3. Baxter: AK 95, AK 96, AK 98 45685 Haemodialysis system Institutional / Home-Use Model: 107012, 107119, 110656, 114742, 115250, 955404, 955604 MHRA reference: 34599078   2025/001/028/601/056 MHRA reference: 34599078   2025/001/028/601/056 – Home Patient Letter MHRA reference: 34599078   2025/001/028/601/056 – Attachment 1
4. BRAINLAB: Multidisciplinary medical image management SW CAPA-20250117-002791 Origin Data Management Model: 30074-04B, 30074-04C MHRA reference: 34641428   2025/002/005/601/017
5. Dexcom: Dexcom G6 Receiver January/February 2025 Percutaneous glucose monitoring system Model: MT24078-1 (mg/dL), MT24078-2 (mmol/L) MHRA reference: 34652451   2025/001/009/601/082
6. Drager: Ventstar Flex breathing circuits 45689 MHRA reference: 34630476   2025/002/004/601/068
7. Gama Healthcare: Clinell Contiplan 45680 MHRA reference: 34613318    2025/001/023/601/049
8. Hamilton Medical: In2Flow Nasal cannula (sizes S, M, L) 45694 Nasal oxygen cannula, basic Model: 10076606, 10076605, 10076604 MHRA reference: 34649940    2025/002/006/601/042 MHRA reference: 34649940    2025/002/006/601/042
9. Hologic: Panther Fusion Tube Trays 45687 Model: FAB-15004 MHRA reference: 34601187   2025/001/031/601/061
10. KLS Martin: OR light system (marLED E marLED X) 45635 Op./ex./treatm light mount,fix MHRA reference: 34603880   2024/012/010/601/022
11. Medtronic: 37307: Activa™ SC 48054: Pocket Adaptor 45658 MHRA reference: 34613389    2024/005/014/601/019
12. Steris: Cataract Set and Zeiss Microscope Caps 45681 MHRA reference: 34606148   2024/012/031/601/075

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