Search
© IHEEM 2026. All rights reserved.

Field Safety Notices (FSNs): 15/06/26 – 19/06/26

IRICIncident Reporting &
Investigation Centre

Reporting | Learning | Prevention

Circulation

DL1 NHS Incidents and alerts Safety Officers

DL2 Local Authority Incidents and alerts Safety Officers

DL3 Specialist Liaison Group

DL4 Product Specialists

DL5 General list (internal)

DL7 General list (external)

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) 15/06/26 – 19/06/26

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. Accuray: CyberKnife 46170 Linear accelerator system MHRA reference: 39884724 2026/006/005/601/078
  2. Balt Extrusion: HYBRID 46190 Hydrophilic guidewire MHRA reference: 39900865 2026/006/018/601/130
  3. Doccla: Virtual Ward 46174 Self-care monitoring/reporting software MHRA reference: 39866652 2026/006/011/601/038
  4. GE Healthcare: Carestation 600 and 750 Series Ref 34142-C2 MHRA reference: 39889683 2025/003/031/601/055
  5. Integra LifeSciences: IntegraOmni-Tract Table Mounted Retractor System 46184 Surgical retraction systems, reusable MHRA reference: 39867776 2026/005/026/601/077
  6. Intersurgical: One-piece Guedel airway 46191 Sterile and non sterile one-piece Guedel airway MHRA reference: 39903289 2026/006/016/601/103
  7. Medtronic: Sphere-9 catheter May 2026 FA1546 Model: AFR-00001 MHRA reference: 39899623 2026/003/006/601/106
  8. Olympus: High Flow Insufflation Unit 46189 Laparoscopic insufflators Model: UHI-4 MHRA reference: 39890870 2026/006/010/601/071
  9. Philips: BiPAP A30(Hybrid)/A40/A40Pro Ventilator(Res.,Inc.) 46151 Portable electric ventilator MHRA reference: 39889347 2024/003/027/601/074
  10. Siemens Healthcare: Atellica CI Analyzer, Atellica IM Analyzer,  ADVIA Centaur XP System, ADVIA Centaur XPT System, ADVIA Centaur CP System 46143 MHRA reference: 39887570 2025/004/015/601/086
  11. Symbios Orthopedie: CoCr Modular Neck assembled with SPS Modular Stem 46191 MHRA reference: 39899492 2026/006/016/601/066

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: Vestel UK Plugs in Various Televisions (2606-0078)

2.     Product Safety Report: Vestel UK Plugs in Bush TiVo Televisions sold by Argos (2606-0164)

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

——————————————————————————————————————————————————–
This email is intended for the named recipient only. If you have received it by mistake,
please (i) contact the sender by email reply; (ii) delete the email from your system; .
and (iii) do not copy the email or disclose its contents to anyone.

——————————————————————————————————————————————————–

You need to be a member and logged in to see this content.