Field Safety Notices (FSNs): 04/05/26 – 08/04/26

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: Easee One EV Charger Backplate BP-AP-1/s01-01 (2604-0019)

2.     Product Recall: Babysense Max View Wireless Digital Video Baby Monitor (2604-0191)

Section 2: medical devices 04/05/26 – 08/05/26

1. Abbott Medical : Infinity and Proclaim 46113 GMDN codes: 37307, 64970 Model: 6660, 6661, 6662, 6663, 3660, 3661, 3662, 3363, 3664, 3665, 3667 MHRA reference: 39442964  2026/004/023/601/064
2. Abiomed, Inc: Impella Purge Cassette 46112 Infusion Pump Cassette Model: 0043-0001;0043-0009 MHRA reference: 39420703  2026/004/002/601/034
3. Bayer Medical Care Inc. : MEDRAD Avanta Multi-Patient Disposable Set 46143 MHRA reference: 39438717  2026/005/006/601/082 MHRA reference: 39438717  2026/005/006/601/082 – Customer reply form
4. Boston Scientific Neuromodulation Corporation: TCN and CSK Reusable RF Electrodes 46147 MHRA reference: 39331784  2026/004/029/601/083
5. ELLA-CS: SX-ELLA Stent Danis (Danis stent) 46142 Polymer-metal oesophageal stent MHRA reference: 39392653  2026/004/029/601/071
6. GE Medical Systems Information Technologies, Inc : ApexPro CARESCAPE Telemetry Server FMI 36169 MHRA reference: 39439984  2026/005/005/601/057
7. Hamilton Medical AG: IntelliCuff 46146 MHRA reference: 39440437  2026/005/005/601/046
8. Intuitive Surgical, Inc: Da Vinci 5 Tower – Model: T5000 ISIFA2026-03-C Model: 380746 MHRA reference: 39427051  2026/005/005/601/135
9. Medtronic, Inc : Pocket Adaptor Kit for Deep Brain Stimulation 46143 Model: Model 64001 and 64002 MHRA reference: 39442821  2026/004/016/601/072
10. PFM Medical Mepro GmbH: Multi-Snare FSN-2026-01 Description : Intravascular extraction catheter-snare MHRA reference: 39331189  2026/004/029/601/080
11. Philips Medical Systems Nederland BV : Philips Allura and Azurion systems 46142 Stationary angiographic x-ray system, digital Model: 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722015, 722022, 722023, 722025, 722026, 722027, 722028, 722029, 722033, 722035, 722038, 722039, 722058, 722059, 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228, 722400 MHRA reference: 39395062  2026/004/030/601/087
12. Pie Medical Imaging B.V. : 3mensio Workstation 46113 Radiology DICOM image processing application softw Model: 10.7, including service packs 1-5 (SP1-5) MHRA reference: 39441813  2026/005/006/601/144 MHRA reference: 39441813  2026/005/006/601/144 – User letter
13. The Binding Site Group Limited : EXENT® Elution Buffer 1 46142 MHRA reference: 39441213  2026/004/024/601/016

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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