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Field Safety Notices (FSNs): 31/08/26 – 04/09/26

IRICIncident Reporting &
Investigation Centre

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DL2 Local Authority Incidents and alerts Safety Officers

DL3 Specialist Liaison Group

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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) 31/08/26 – 04/09/26

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. Acumed: Acu-Loc 2 46261 Model: Acu-Loc 2 VDR Plt Std L MHRA reference: 40679952 2026/008/028/601/038
  2. Carnamedica: Belzer UW Cold Storage Solution, Belzer MPS 46258 MHRA reference: 40687391 2026/008/013/601/181
  3. Edwards Lifesciences: ForeSight Oximeter Cable 46245 General-purpose multi-parameter bedside monitor MHRA reference: 40686601 2026/008/005/601/078
  4. GE Healthcare: Centricity High Acuity Anesthesia / Critical Care Ref 38018 Patient health record information system MHRA reference: 40681769 2026/008/028/601/128
  5. GE Healthcare: Centricity PACS; Enterprise Archive Ref 85492 MHRA reference: 40693494 2026/008/013/601/145
  6. Heraeus Medical: PALACOS R+G pro, PALACOS MV+G pro, COPAL G+C pro Ref FSN-HME-2026-02-EN Orthopaedic prostheses cements MHRA reference: 40679488 2026/008/013/601/021
  7. Löwenstein Medical: Leoni Plus 46235 MHRA reference: 40697690 2026/006/025/601/076
  8. NORTHERN DIGITAL: NDI Passive Spheres 46266 Imaging lesion localization marker, external Model: 8801071, 8801074, 8801075 MHRA reference: 40709365 2026/008/028/601/055
  9. Philips: MR systems with SW versions R5 & R11 46235 MHRA reference: 40725654 2026/008/026/601/039
  10. Saladax Biomedical: MyCare Insite Total Aripiprazole Test 46265 Aripiprazole therapeutic drug monitoring IVD, reagent MHRA reference: 40710070 2026/008/024/601/101
  11. Summit Medical: HiVac MultiMix Ref FSCA-007 Orthopaedic cement preparation/delivery kit MHRA reference: 40719475 2026/009/002/601/137
  12. W.L. Gore: GORE VIABAHN Endoprosthesis 46267 Peripheral artery endovascular stent-graft MHRA reference: 40709534 2026/008/028/601/167

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

Page summaryUpdate / change
Nonen/a

Section 3: estates, facilities or general products

  1. 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

e: nss.iric@nhs.scot

m: 0131 275 7575

publicservicesdelivery.scot

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

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