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Field Safety Notices (FSNs): 23/03/26 – 27/03/26

IRICIncident Reporting &
Investigation Centre

Manufacturers’ Field Safety Notices

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DL1 NHS Incidents and alerts Safety Officers

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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

1.     Product Recall: Joie Serina Elephant Duo Swivel Baby Swing (2603-0090)

2.     Product Recall: Silentnight Smart Wi-Fi Plug (2602-0174)

3.     Product Safety Report: Rainbow Mix Jelly Water Gel Beads sold via Desertcart (2508-0086)

4.     Product Recall: Søstrene Grene LED String Lights (2603-0149)

5.     Product Safety Report: Metador Defender Fire Doorsets (2512-0236) updated

Section 2: medical devices 23/03/26 – 27/03/26

  1. Advanced Bionics: M Zn Air Battery Pak 46104 Cochlear implant/auditory brainstem implant batter MHRA reference: 38958648 2026/003/025/601/149
  2. Canon Medical Systems: Vantage Galan and Vantage Titan 46097 Full-body MRI system, superconducting magnet Model: MRT-3020 and MRT-3010 MHRA reference: 38929487 2026/001/030/601/159
  3. Cristalens: Lens, Intraocular Lens 46094 Model: ARTIS PL E / ARTIS Symbiose MHRA reference: 38950598 2026/003/025/601/090
  4. Heraeus: PALAMIX uno / PALAMIX duo 46101 Model: 66057893; 66057897 MHRA reference: 38975280 2026/003/016/601/066
  5. Hologic: 3Dimensions and Selenia® Dimensions 46106 X-ray System, Diagnostic, Mammographic, Stationary MHRA reference: 38968793 2026/003/026/601/068
  6. Intuitive Surgical: 8mm SureForm 30 Gray Reload Ref ISIFA2026-02-R Surgical staple, non-bioabsorbable Model: 48230M-05 and 48230M-06 MHRA reference: 38958239 2026/003/025/601/123
  7. Jiangsu Micsafe Medical Technology: Safety Needle 46101 Model: 25G x 5/8”(0.5 x 16mm) MHRA reference: 38899973 2026/003/023/601/005
  8. MENTOR: CPX 4 Tissue Expanders 46084 Skin-port tissue expander MHRA reference: 38906522 2026/002/025/601/043
  9. MyWam: GRIZZLY 46055 MHRA reference: 38923982 2026/003/023/601/035
  10. Philips: Vue PACS v12 46059 MHRA reference: 38906039 2026/003/005/601/059
  11. Philips: Trilogy Evo; Trilogy Evo O2; Trilogy EV300 46062 Portable Electric Ventilator MHRA reference: 38927948 2026/002/011/601/010
  12. Philips: Azurion, Allura Xper, Allura Centron, Allura CV20 46079 Stationary angiographic x-ray system, digital Model: 722001, 722002, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722015, 722020, 722022, 722023, 722025, 722026, 722027, 722028, 722029, 722031, 722033, 722035, 722038, 722039, 722058, 722059, 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228, 722229, 722230, 722231, 722232, 722233, 722234, 722235, 722236, 722280, 722281, 722282, 722400 MHRA reference: 38906391 2026/003/003/601/073
  13. Philips Respironics: BiPAP A40 Pro Ventilator (Respironics, Inc.) 46062 Portable Electric Ventilator MHRA reference: 38927570 2024/006/021/601/078
  14. Remel: YEASTONE BROTH, 11ML, 10/BOX 46112 MHRA reference: 38940881 2026/003/023/601/067
  15. Smith & Nephew: PROX STR HUMERAL NAIL 8/7 X 16 46097 Humerus intramedullary nail MHRA reference: 38918641 2026/003/020/601/086

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 summaryChange(s) made
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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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