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Field Safety Notices (FSNs): 10/08/26 – 14/08/26

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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) 10/08/26 – 14/08/26

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. AMO Uppsala: Healon EndoCoat PRO, Healon Duet PRO II 46233 Model: 10301012, 10301016 MHRA reference: 40516806 2026/007/028/601/014
  2. Cardiac Pacemakers: LATITUDE Clarity Data Management System 46248 Information system software, application program MHRA reference: 40482868 2026/008/010/601/076
  3. Cook: Hemospray Endoscopic Hemostat 46240 Non-organic haemostatic agent Model: HEMO-7-EU, HEMO-7, HEMO-10-EU, HEMO-10 MHRA reference: 40505369 2026/007/016/601/189
  4. East Midlands Pharma: Vizulize Flight Pack Contact Lens Care 46220 MHRA reference: 40516717 2026/007/021/601/072
  5. Fresenius: Smartbag – Liquid Acid Concentrates 46234 Model: F00005286, F00007046, F0000232D, F00007960, F0000065D, F0000068D, F0000067D, F00007041, F0000066D, F0000064D, F00007575, F00007959, F00005537, F00005287, F0002007D, F00006560, F00007962, F00007961, F00007958, F00006557, F00005538, F00007043, F00007957, F00007576, F00006883 MHRA reference: 40469610 2026/008/004/601/165
  6. Heidelberg Engineering: SPECTRALIS with Flex Module 46246 MHRA reference: 40507932 2026/008/012/601/166
  7. Hyaltech: Visthesia 1.0% & Visthesia 1.5% (including intra) 46238 MHRA reference: 40511907 2026/008/005/601/027
  8. Ivor Shaw: Various Procedure Packs – ChloraPrep 1mL Applicators 46216 MHRA reference: 40183625 2026/007/013/601/183
  9. One Rehab: Illusion Mobility Scooter 46204 Assistive scooter, electric-motor-driven MHRA reference: 40481844 2026/007/001/601/021
  10. Philips: Azurion systems 46219 Interventional Fluoroscopic X-Ray System Model: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228, 722229, 722230, 722231, 722232, 722233, 722234, 722235, 722236, 722280, 722281, 722282 MHRA reference: 40472768 2026/007/020/601/038 R2.x.10 systems MHRA reference: 40472768 2026/007/020/601/038 R3.1 systems MHRA reference: 40472768 2026/007/020/601/038 R3 systems MHRA reference: 40472768 2026/007/020/601/038 R4 systems
  11. Philips: EPIQ Elite Diagnostic Ultrasound system August 2026 ref 2026-PD-US-009 Ultrasound system, Imaging, General Purpose Model: 795234 MHRA reference: 40497029 2026/008/007/601/057
  12. Philips: IntraSight Plus 46235 Model: 797423 MHRA reference: 40485018 2026/008/010/601/057
  13. TRx Orthopaedics: OrthoPure XT Ligament Reconstruction Implant 46240 Ligament xenograft Model: Size 5, Size 6, Size 8 & Size 10 MHRA reference: 40470235 2026/008/007/601/021

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

Page summaryUpdate / change
NoneNone

Section 3: estates, facilities or general products

1.    Product Recall: Bull and Cygnus Fire Alarm Detection System (FADS) (2607-0120)

2.    Product Recall: Simple 730ml Kind to Skin Micellar Cleansing Water (2608-0103)

3.    Product Safety Report: Out’n’About ATP Ltd Nipper V6 Buggy (2606-0149)

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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