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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) 07/09/2026 – 11/09/2026
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.
- Howmedica Osteonics: Orthopaedic implant components 46235 MHRA reference: 40685132 2026/008/024/601/071
- Innovacon: InstAlert hCG Strip (Urine) 46253 Model: 4564649001 MHRA reference: 40777750 2026/009/001/601/188
- Instrumentation Laboratory: HemosIL AcuStar HIT-IgG(PF4-H) 46268 Platelet factor 4-heparin complex antibody IVD MHRA reference: 40740115 2026/009/004/601/112
- JenaValve: Trilogy Transcatheter Heart Valve System 46234 MHRA reference: 40787025 2026/009/001/601/171
- Shimadzu: FDR Visionary Suite 46217 MHRA reference: 40764835 2026/008/020/601/001
- Smith & Nephew: EVOS 46268 Orthopaedic fixation plate, non-bioabsorbable Model: EVOS 3.5MM PARTIAL ARTICULAR LATERAL PROXIMAL TIBIA PLATE 6 HOLE LEFT 91MM & VOS 3.5MM LATERAL PROXIMAL TIBIA PLATE 6 HOLE LEFT 91MM MHRA reference: 40786556 2026/009/007/601/014
Section 2: updates and changes to previously published medical device FSNs
| Page summary | Update / change |
| N/A | 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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