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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) 13/07/26 – 17/07/26
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.
- GE Healthcare: MAC VU360 Resting ECG Analysis System Ref 30123 Electrocardiograph, professional, multichannel MHRA reference: 40226313 2026/007/016/601/087
- Kayserbetten: Paediatric care beds 46213 Model: Olaf, Mascot, Escot (Emma and Ida), standard Emma, Ida Including specials of these beds MHRA reference: 40164811 2026/006/029/601/030
- Medcaptain: Disposable Infusion Set 46204 Model: A211M /A211M1F /A211M5F1/A311M/A311M021F/A212 MHRA reference: 40179552 2026/007/013/601/011
- Medtronic: Sphere-360 Catheter July 2026 FA1586 Model: AFR-00012 MHRA reference: 40194215 2026/007/014/601/041
- Philips: Philips Allura Systems 46206 Stationary angiographic x-ray system, digital Model: Allura Xper FD10 722026, Allura Xper FD10/10 722027, Allura Xper FD20 722028, Allura Xper FD20/10 722029, Allura Xper FD20 OR Table 722035, Allura Xper FD20/20 722038, Allura Xper FD20/20 OR Table 722039, Allura Xper FD20/15 722058 MHRA reference: 40234701 2026/007/001/601/062
- Philips: Cardiac Workstation 5000,Cardiac Workstation 7000 46232 Model: 860439,860441 MHRA reference: 40197672 2026/007/002/601/095
- RaySearch Laboratories: RayCare 46213 MHRA reference: 40166272 2026/007/010/601/122
- Siemens Healthcare: Atellica C H Urine Albumin (UAlb) 46204 Albumin IVD, kit, nephelometry/turbidimetry MHRA reference: 40165746 2026/007/002/601/067
- STAAR Surgical: Brand 46177 ICL/TICL Calculator/IOD Software MHRA reference: 40183060 2026/005/006/601/165
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
- None
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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