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Manufacturers’ Field Safety Notices
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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
- Product Safety Alert: Water Beads (PSA7)
- Product Recall: ISEO F6 Extra/R700 European Cylinder Locks (Thumbturn Versions) (2406-0041)
- Product Recall: 3M Peltor X4A Noise Cancelling Headphones (2409-0022)
- Product Recall: Pro Breeze 2L Air Fryer 1000W with Digital Display sold via Amazon and Probreeze.com (2409-0044)
- Product Recall: Pifco 2KW Convector Heater with Turbo and Timer sold by Home Bargains (2409-0045)
- Product Recall: Taf Toys Savannah & Urban Garden Foam Playmats (2409-0034)
- Product Recall: Weasel and the Whale Dummy Clip – Liberty Print Fabric sold via Etsy (2404-0155)
- Product Recall: My Babiie Infant Carriers (2409-0014)
Section 2: medical devices 16/09/24 – 20/09/24
- Philips: Azurion, Allura Xper, Integris and MultiDiagnost Eleva 45526 Interventional Fluoroscopic X-Ray System Model: Refer to FSN Serial numbers: See Units Affected List for C&R 2023-IGT-BST-006 MHRA reference: 31896827 2024/008/027/601/009
- Ziehm Imaging: Several Ziehm device types and OEM products 45439 VARIOUS DIAGNOSTIC AND INTEROPERATIVE BIOIMAGING MHRA reference: 31896162 2024/009/013/601/066
- Getinge: Leg holder 45386 Leg procedure positioner Model: 1003.80A0 MHRA reference: 31895217 – FSN 2024/004/009/601/015 MHRA reference: 31895217 – Reply form
- Swemac Innovation AB: Motec Wrist Radius Hemi Prosthesis 13.09.2024 Updated FSN Model: All batches/lots MHRA reference: 31909312 2024/005/006/601/075
- Bruker Daltonics: UMIC Colistin 11.July.2024 Model: 240410COL, 240418COL, 240506COL MHRA reference: 31895212 2024/077/012/601/014
- Serres Oy: Pre-gelled bag 2000 ml 45161 Model: 57567-0, LOT. 1109986 MHRA reference: 31879748 2023/009/006/601/032
- Exmoor Plastics Ltd: Exmoor Plastics Nasal Splints 45022 Nasal splints Model: Refer to FSN MHRA reference: 31866862 2023/003/028/601/038
- Abbott: Alinity m System, Alinity m HR HPV AMP Kit & Alinity m STI AMP Kit 45546 Model: Refer to FSN MHRA reference: 31945167 2024/009/016/601/026
- illumina: NovaSeq 6000Dx Instrument including DRAGEN Server, Illumina DRAGEN Server for NextSeq 550Dx 45552 Nucleic acid sequence analyser IVD, NGS Model: 20068232 MHRA reference: 31945051 2024/009/016/601/016
- Royal College of Obstetricians & Gynaecologists (RCOG): Tommy’s Pathway: Clinical Decision Support Tool Version: 1.8.7 13.09.2024 MHRA reference: 32397983 2024/009/009/601/079
- Semeda: ALFA-Flex, BETA-Flex 16.07.2024 Orthosis ankle/foot. Foot abduction splints Model: Refer to FSN MHRA reference: 32352074 2024/009/011/601/074
- Olympus: Thunderbeat Type – S 45195 Soft-tissue ultrasonic surgical system holder/tip Model: TB-0535FCS for Thunderbeat Type S, 35 cm and TB-0545FCS for Thunderbeat Type S, 45 cm MHRA reference: 32400906 2024/008/020/601/020
- Olympus: Thunderbeat Type – S – Updated FSN 45307 Soft-tissue ultrasonic surgical system holder/tip Model: TB-0535FCS for Thunderbeat Type S, 35 cm and TB-0545FCS for Thunderbeat Type S, 45 cm – Refer to FSN for additional LOT numbers MHRA reference: 32426598 2024/008/020/601/020
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
| Page summary | Change(s) made |
| n/a | n/a |
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)
NHSScotland Assure
NHS National Services Scotland
IRIC operates incident learning and prevention systems for medical devices, IVDs, estates, facilities, social care equipment and PPE
Tel: 0131 275 7575 | nss.iric@nhs.scot | report incidents | safety alerts | Turas Learn | Intro to IRIC short video
We are NHS National Services Scotland. We offer a wide range of services and together we provide national solutions to improve the health and wellbeing of the people of Scotland. Find out more in our NSS Strategic Framework 2024-2026
FAC406-212, 8B(i), Rev 7
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