Field Safety Notices (FSNs): 17/11/25 – 21/11/25

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: Deltronic Security AB Environmental Alarm (2511-0104)

Section 2: medical devices 17/11/25 – 21/11/25

1. Abbott: Alinity ci-series System Control Module (SCM) 45974 Chemiluminescent immunoassay analyser IVD MHRA reference: 37701961 2025/011/017/601/032
2. Abbott: Alinity ci-series System Control Module (SCM) FA13NOV2025 Chemiluminescent immunoassay analyser IVD MHRA reference: 37683459 2025/011/017/601/031
3. Abbott: FreeStyle Libre 3 and 3 Plus Sensors November 2025 FA1002-2025 Invasive interstitial-fluid glucose monitoring sys MHRA reference: 37681978 2025/011/017/601/100
4. Balt Extrusion: HYBRID 45961 Cardiac/peripheral vascular guidewire, single-use Model: HYBRID007D MHRA reference: 37682846 2025/011/017/601/057
5. Beckman Coulter: Access 2 Reaction Vessel 45968 General specimen container IVD, no additive/medium MHRA reference: 37669105 2025/011/003/601/030
6. BIOSYNEX: AMNIOQUICK CARD, AMNIOQUICK DUO+ 45968 MHRA reference: 37706038 2025/011/019/601/008
7. Cepheid: Xpert BCR/ABL Ultra 45972 MHRA reference: 37723157 2025/011/019/601/056
8. Micro Therapeutics: Riptide Large Bore Aspiration Tubing 45962 Suction / Irrigation tubing, single-use Model: MAT-110-110 MHRA reference: 37705696 2025/011/007/601/042
9. NICO CORP: NICO Myriad System, Illumination Pack, BrainPath 45952 Myriad Illumination Pack MHRA reference: 37683630 2025/011/017/601/047
10. Philips: Height Adjustable (HA) FlexTrak Trolley (Update to FSN 30469738) 45945 Model: 989710006411, 989710006412, 989710008732, 989710008733 MHRA reference: 37673250 2024/005/013/601/012
11. Remel: CAMHB W/LHB MANUAL & BRUCELLA BROTH 11ML 10/BOX 45981 MHRA reference: 37712806 2025/011/019/601/048
12. Rocket Medical: Rocket Seldinger Chest Drain Kit 45946 Non-vascular catheter introduction set MHRA reference: 37684145 2025/010/023/601/088
13. Schiller Medical: Monitor Defibrillator 45962 Monitor Defibrillator Model: DEFIGARD Touch-7 MHRA reference: 37688755

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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