Field Safety Notices (FSNs): 06/04/26 – 10/04/26

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)

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 but 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 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 2 lists FSNs for medical devices brought to our attention specifically by Medicines and Healthcare products Regulatory Agency (MHRA).

Section 1: estates, facilities or general products

1.     Product Safety Report: Zoeller Lifting Systems (2603-0140)

2.     Product Recall: BleuRibbon Baby Shop Baby Self-Feeding Pillow (2603-0052)

3.     Product Recall: Matalan Baby Sleeping Bags (2603-0245)

Section 2: medical devices 06/04/26 – 10/04/26

1. Allurion: Elipse Gastric Balloon System 46108 Balloon, gastric, appetite-suppressing Model: 10D MHRA reference: 39095450 2026/004/002/601/160
2. Bonree Medical: GenCath Open Suction Catheter 46113 MHRA reference: 39132092 2026/004/009/601/041
3. Boston Scientific: POLARx & POLARx FIT, POLARSHEATH, SMARTFREEZE 46121 MHRA reference: 39107001 2026/004/007/601/051
4. BVI Liège/ PhysIOL: PODEYE 46121 Intraocular Lens posterior chamber pseudophakic Model: PODAGF+21.5, PODAGF+23.0, PODAGF+24.0 MHRA reference: 39124618 2026/004/003/601/045
5. Edwards Lifesciences: EVOQUE Tricuspid Delivery System 46112 Tricuspid transcatheter heart valve bioprosthesis Model: 9850TDS MHRA reference: 39063549 2026/003/026/601/112
6. GE HealthCare: Revolution Ascend Ref 23015 Full-body CT system MHRA reference: 39103793 2026/004/007/601/073
7. Intuitive Surgical: da Vinci X & Xi Surgical System Ref ISIFA2026-01-C Robotic Surgical System Model: IS4000 Surgical System; IS4200 Surgical System MHRA reference: 39122168 2026/004/008/601/069
8. Medline: Angiographic Control Syringe with Rotating Adaptor 09 April 2026 FSN-26-04 MHRA reference: 39131949 2026/004/009/601/055
9. Medline: Angiographic Control Syringe with Rotating Adaptor 09 April 2026 FSN-26/05 MHRA reference: 39133197 2026/004/009/601/024
10. Medline: Angiographic Control Syringe with Rotating Adaptor Ref FSN-26-03 MHRA reference: 39137125 2026/004/009/601/047
11. MEQU: M Warmer 46112 Model: MWS201 MHRA reference: 39094898 2026/004/002/601/108
12. Merivaara: Q-Flow surgical lights 46112 Operating room light system Model: Q-FLOW SOLO, Q-FLOW DUO, Q-FLOW TRIO, Q-FLOW QUAD, Q-FLOW MOBILE MHRA reference: 39092943 2026/004/002/601/114
13. Rand: ILP HT 46114 Intravascular/intracavitary-circulation hyperthermia system set MHRA reference: 38990822 2026/003/027/601/012
14. Remel: OXOID Agglutinating Sera, Salmonella 9-0 46100 MHRA reference: 39107701 2026/003/023/601/077
15. Renishaw Mayfield: neuromate stereotactic surgery system – Headholder 46120 MHRA reference: 39150197 2026/003/025/601/050

The above 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. 

Section 3: updates and changes to previously published medical device FSNs

Adverse Incidents

Incidents and near-misses should always be reported to local incident management systems (often referred to as Datix, Ullyses, 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
• In vitro diagnostic devices or IVDs, e.g. blood analyser, reagent, SARS-CoV-2 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 7

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