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Field Safety Notices (FSNs): 20/07/26 – 24/07/26

IRICIncident Reporting &
Investigation Centre

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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: medical devices field safety notices (FSNs) 20/07/26 – 24/07/26

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. 

  1. Aesculap: Silver Graft (Helix) Vascular Prosthesis 46225 Synthetic vascular graft, non-medicated MHRA reference: 40303319 2026/007/015/601/237
  2. BioFire Diagnostics: BIOFIRE FILMARRAY TORCH Base 46225 Thermal cycler nucleic acid amplification analyzer Model: Shipping Configuration: HTFA-ASY-0001, Part Number: HTFA-ASY-0104 MHRA reference: 40252368 2026/007/017/601/103
  3. GE Medical Systems: Optima XR200amx and Optima XR220amx 46209 X-ray system,diagnostic,General-Purpose,Portable MHRA reference: 40236215 2026/006/026/601/052
  4. Hamilton: Breathing circuit set, coaxial 46224 MHRA reference: 40284619 2026/005/018/601/065
  5. Immucor: Panocell-16 46223 MHRA reference: 40283274 2026/007/021/601/152 Customer Letter MHRA reference: 40283274 2026/007/021/601/152 Distributor Letter
  6. Lisclare: Go 46108 Model: Go HighBack Sling (Clip) — Small MHRA reference: 40303415 2026/007/022/601/126
  7. Löwenstein: elisa 300, elisa 500, elisa 600, elisa 800 (VIT) 46204 Critical Care Ventilator MHRA reference: 40266406
  8. Olympus: Evis Exera III Colonovideoscope 46199 Flexible video colonoscope, reusable Model: PCF-HQ190L MHRA reference: 40286569 2026/006/018/601/081
  9. Soluscope: SOLUSCOPE SERIE 4, SERIE 3 and SPRINT PT 46154 Model: All installed base MHRA reference: 40234566 2026/001/020/601/058
  10. Thermo Fisher Scientific: Neisseria meningitidis Gp C 2ml/VL 46219 MHRA reference: 40236287 2026/007/016/601/148

Section 2: updates and changes to previously published medical device FSNs

Page summaryUpdate / change
Nonen/a

Section 3: estates, facilities or general products

1.    Product Safety Report: Dunelm Warm and Cosy Electric Blanket Cables (2607-0039)

2.    Product Safety Report: TOMY UK Boon PIVOT Toddler Tower sold via Amazon (2607-0146)

3.    Product Safety Report: PCL Push Button Safety (PBS) Coupling (2605-0179)

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

e: nss.iric@nhs.scot

m: 0131 275 7575

publicservicesdelivery.scot

FAC406-212, 8B(i), Rev 8

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