Field Safety Notices (FSNs): 11/05/26 – 15/05/26

Manufacturers’ Field Safety Notices

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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 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) 11/05/26 – 15/05/26

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. 

1. Abbott: MERLIN PATIENT CARE SYSTEM 46143 Application Software Model: 3650 MHRA reference: 39502157 2026/005/012/601/036
2. Balt Extrusion: Silk Vista 46149 Self-expandable intracranial stent Model: SILK_V 4,25X20 MHRA reference: 39521664 2026/005/013/601/098
3. Bosch Healthcare Solutions: Vivalytic STI 46146 Chlamydia trachomatis nucleic acid IVD, kit Model: F09G300078 MHRA reference: 39502197 2026/005/008/601/019
4. GE Medical Systems: CASE Cardiac Testing System Ref 30121 Interpretive multichannel electrocardiograph MHRA reference: 39500258 2026/005/012/601/042
5. In2Bones: NeoSpan SuperElastic Compression Staple 46150 Orthopaedic bone staple, non-adjustable MHRA reference: 39532782 2026/005/013/601/019
6. Instrumentation Laboratory: HemosIL Heparin Calibrators 46085 MHRA reference: 39470684 2026/005/008/601/147
7. Intuitive Surgical: da Vinci SP Surgical System – Patient Cart 46155 Robotic surgical telemanipulation system Model: 380601 MHRA reference: 39482510 2026/005/011/601/101
8. Invacare: Robin 46153 Mobile patient lifting system electrically-powered Model: 1493471-7035 MHRA reference: 39486427 2026/005/011/601/083
9. SOL Group LAB: Penelope 2.0 46134 MHRA reference: 39282023 2026/004/024/601/075
10. STAAR Surgical: ICL/TICL Calculator/IOD Software 46132 MHRA reference: 39500119 2026/005/006/601/165
11. Stryker: Stryker T7 Zippered Togas, HP, AR, XL 46113 MHRA reference: 39470647 2026/005/008/601/010

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

Section 1: estates, facilities or general products

1.     Product Recall: Centurion Full Face Mask Respirator (2603-0139)

2.     Product Recall: DeWALT Full Face Respirator (2603-0136)

3.     Product Recall: Yaheetech Velvet Convertible Sofa Bed (2604-0178b)

4.     Product Recall: Yaheetech Barrel-Shaped Chair (2604-0178a)

5.     Product Safety Report: FAI TOP High Pressure Washer Gun sold via Amazon (2604-0206)

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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