Field Safety Notices (FSNs): 18/05/26 – 22/05/26

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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) : 18/05/26 – 22/05/26

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. 

Armstrong Medical: APL Valve UPDATE 46143 MHRA reference: 39615352 2026/003/006/601/108

Astor Bannerman: Astor Carlo Eco Mobile Hoist with Lift Scales UPDATE 46154 MHRA reference: 39585468 2025/010/008/601/061

Boston Scientific: CRE Wireguided Balloon Dilatation Catheter 46168 MHRA reference: 39595712 2026/005/020/601/128

Canon Medical Systems: X-Ray Interventional Systems 46155 Stationary angiographic x-ray system, digital Model: INFX-8000C, INFX-8000F, INFX-8000V, INFX-8000H, INFX-9000V Combined with XIDF-QCA850/A1, /A2, /B1, /B2, /Z2, /Z3 options MHRA reference: 39539789 2026/005/001/601/083

Datex-Ohmeda: Giraffe OmniBeds – Giraffe OmniBed Carestations Ref 32101 Incubator, infant MHRA reference: 39549790 2026/005/015/601/095

Hamilton: Breathing circuit set, coaxial 46160 MHRA reference: 39566574 2026/005/018/601/065

Howmedica Osteonics: Triathlon CS X3 Tibial Insert 46113 MHRA reference: 39577377 2026/004/016/601/052

LUTRONIC Corporation: CLARITY II 46063 MHRA reference: 39539118 2026/002/013/601/143

Medtronic: Octopus Tissue Stabiliser May 2026 FA1541 Patient positioning vacuum pad Model: TSMICS1, TS2500, TS2000, 29400 MHRA reference: 39549196 2026/005/005/601/040

MicroVention: BOBBY Balloon Guide Catheter UPDATED 46142 MHRA reference: 39591374 2026/004/028/601/122

Philips: Allura Xper, Allura Centron, Allura CV20, MD-Eleva 46160 Stationary angiographic x-ray system, digital Model: 708032, 708034, 708036, 708037, 708038, 722001, 722002, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722015, 722019, 722020, 722022, 722023, 722025, 722026, 722027, 722028, 722029, 722031, 722033, 722035, 722038, 722039, 722058, 722059,722400 MHRA reference: 39585195 2026/005/019/601/081

Siemens: ARTIS icono 46143 Stationary angiographic x-ray system, digital MHRA reference: 39597094 2026/005/020/601/137 FSN MHRA reference: 39597094 2026/005/020/601/137 FIELD CORRECTION EFFECTIVENESS CHECK

Surgical Specialties: Katena 46134 Model: 72-2231 MHRA reference: 39233656 2026/004/017/601/110

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

Section 3: estates, facilities or general products

1.     Product Recall: My Little Chick Dummy Clip (2601-0406)

2.     Product Recall: Vevor Lifting Chains (2605-0053)

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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