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Outlook tags IRICSW$i0 (safety alert – general), IRICSW$i5 (field safety notices)
Dear colleague
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 and 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 FSNs for medical devices brought to our attention specifically by Medicines and Healthcare products Regulatory Agency (MHRA).Section 2
- Section 2 lists changes to previously published FSNs.
- Section 3 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 1: medical devices field safety notices (FSNs) 25/05/26 – 29/05/26
The following 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. Alternatively, to search or browse a spreadsheet maintained by MHRA which details all FSNs issued since 2020, please click here.
- Elekta: MOSAIQ Oncology Information System 46143 Linear Accelerators – Software Accessories MHRA reference: 39662772 2026/004/030/601/029
- Epocal: Epoc BGEM Test Cards 46143 MHRA reference: 39661312 2026/005/008/601/126
- GE Medical Systems: Allia IGS 3,5,7 and Allia Moveo Ref 18014 Stationary angiographic x-ray system, digital MHRA reference: 39677778 2026/005/013/601/094
- Medtronic: O-arm O2 Imaging System May 2026 FA1542 Model: BI-700-02000 MHRA reference: 39678037 2026/004/029/601/135
- STERIS: NEUTRA-FLUSH + Endoscope Channel Cleanser 46161 Model: 100848K, 100849K, 100850K, 100851K MHRA reference: 39676929 2026/005/019/601/175
- Trividia Health: TRUE METRIX, TRUE METRIX AIR, TRUE METRIX GO 46143 Glucose monitoring system IVD, home-use Model: RE4i82-11; RE4i82-12; REA4i82-11; REA4i82-12; RF4i82-11BK; RF4i82-12BK MHRA reference: 39665275 2026/002/011/601/061
Section 2: updates and changes to previously published medical device FSNs
| Page summary | Update / change |
| None | n/a |
Section 3: estates, facilities or general products
- Product Recall: Wago Limited TOP JOB S Terminal Block (2507-0107)
- Product Recall: 3M Versaflo Intrinsically Safe Powered Air Turbo TR802E (2602-0262)
- Product Safety Report: Infant Sleep Positioner Anti Roll Pillow for Head sold via Wish (2601-0125)
- Product Recall: Maxi-Cosi Family Fix Slide Pro Base (2605-0109)
- Product Recall: Joolz Aer2 Car Seat Adapter Set (2605-0189)
Adverse Incidents
Incidents and near-misses should always be reported to local incident reporting and learning systems (often referred to as Datix, Healthcare Guardian, Evotix, 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
- Software as a medical device, e.g. HEPMA
- In vitro diagnostic devices or IVDs, e.g. blood analyser, reagent, lateral flow 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)
Public Services Delivery Scotland
Gyle Square | 1 South Gyle Crescent
Edinburgh | EH12 9EB
m: 0131 275 7575
FAC406-212, 8B(i), Rev 8
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