Field Safety Notices (FSNs): 15/12/25 – 19/12/25

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)

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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

None

Section 2: medical devices 15/12/25 – 19/12/25

1. Agfa: DR 800 REF: VR0001207 MHRA reference: 37972568 2025/012/015/601/027
2. Elekta: Leksell GammaPlan 45992 RADIOSURGERY INSTRUMENTS – SOFTWARE MHRA reference: 37962708 2025/012/012/601/027
3. Instrumentation Laboratory: HemosIL SynthAFax 45979 Activated partial thromboplastin MHRA reference: 38000136 2025/012/016/601/090
4. Integra LifeSciences: Microsensor /CereLink ICP sensor Basic kit 46003 Intracranial pressure monitor MHRA reference: 38023916 2025/012/004/601/048
5. Intuitive Surgical: ACCESS PORT KIT,WOUND RETRACTOR 46007 Laparoscopic multi-instrument access port, single- Model: 430073 and 430075 MHRA reference: 37985172
6. Philips: Azurion system 46003 Stationary angiographic x-ray system, digital Model: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228, 722280 ,722281, 722282 MHRA reference: 37984672 2025/012/016/601/111
7. SYSMEX CORPORATION: TS-10 Automated Tube Sorted 46006 MHRA reference: 38002838 2025/012/015/601/096
8. Zimmer Surgical: Zimmer Air Dermatome and Zimmer Dermatome AN 46009 Dermatome Handpiece, Pneumatic Model: 00-8801-001-00; 88710100 MHRA reference: 38008530 2025/012/018/601/074

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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