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Manufacturers’ Field Safety Notices
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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
- Product Safety Report: Floson 2m Extension Socket (2507-0010a)
- Product Safety Report: Puning Vinisen Electrical Appliance Co. Ltd Extension Lead (2507-0010b)
- Product Recall: Anker Power Banks A1681, A1689 and A1647 (2507-0045)
- Product Safety Report: Organic Somnum Baby Sleeping Bag (2504-0029)
- Product Recall: Tower Air Fryers (2503-0094) updated
Section 2: medical devices 21/07/25 – 25/07/25
- Avanos Medical: CORFLO* / CORTRAK* 2 Date: 25 July 2025 Description: Nasogastric Feeding Tube Model: 40-7368; 40-7431; 40-7432; 70-7438; 40-9431; 40-9551; 42-1226; 42-1362; 42-2438; 42-7361; 42-7366; 42-7368; 42-7558; 42-8226; 42-9156; 42-9225; 42-9226; 42-9228; 42-9361; 42-9366; 42-9368; 42-9431; 42-9432; 42-9438; 42-9551; 42-9558; 50-4602; 51-4602; 51-9601; 40-9551TRAK2; 40-9558TRAK2; 42-9361TRAK2;42-9362TRAK2; 42-9368TRAK2; 42-9431TRAK2; 42-9551TRAK2;42-9558TRAK2 MHRA reference: 36297769 2025/007/025/601/024
- Boston Scientific: Vercise Genus Implantable Pulse Generator System Update Date: 09 July 2025 Description: Deep brain electrical stimulation system MHRA reference: 36237996 2024/008/008/601/067
- Cardiac Pacemakers, Inc: ENDOTAK RELIANCE Date: 24 July 2025 Description: Lead, defibrillator, implantable MHRA reference: 36230484 2025/007/021/601/095
- GE Healthcare: SIGNA Artist, SIGNA Artist Evo, SIGNA Voyager Date: 18 July 2025 Description: MRI system, full-body, superconducting magnet MHRA reference: 36264563 2025/007/016/601/054
- Max Mobility: SpeedControl Dial used with the Smartdrive MX2+ Ref: FSCA CAPA 24-015 Description: Manual wheelchair, power assist unit Model: MX2-3DC MHRA reference: 36263090 2024/012/011/601/079
- Olympus: Electrosurgical Generator – ESG-410 Date: 27 July 2025 Description: Electrosurgical Units Model: WA91307W MHRA reference: 36278090 2025/007/021/601/076
- Ortho Solutions: T10 Screwdriver bit, self-retaining Date: 24 July 2025 Description: Surgical screwdriver, reusable MHRA reference: 36296438 2025/007/024/601/098
- Ortho-Clinical Diagnostics: VITROS Chemistry Products Calcium Slides Date: 18 July 2025 Description: Calcium (Ca2+) IVD, reagent MHRA reference: 36250390 2025/007/015/601/109
- Philips: Pinnacle Radiation Therapy Planning System Date: July 2025 Description: Radiation therapy software Model: 870258 MHRA reference: 36259374 2025/007/022/601/133
- Shenzhen Amydi-Med Electrics Tech Co Ltd: Reflex Medical Adult Defibrillation Electrodes for CORPULS, Reflex Medical Paediatric Defibrillation Electrodes for CORPULS Date: 23 July 2025 Model: DEF/046 – AMD-DD-AF0017-X, DEF/047 – AMD-DD-PF0017-X MHRA reference: 36260025 2025/007/023/601/051
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
| Page summary | Change(s) made |
| n/a | n/a |
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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