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Manufacturers’ Field Safety Notices
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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
- Product Recall: 3M Scott ELSA, 2000, Emergency Life Support Apparatus (2411-0137)
- Product Recall: 3M Scott ELSA, Sprint, Emergency Life Support Apparatus (2411-0156)
- Product Recall: 3M Scott ELSA, Munster, Emergency Life Support Apparatus (2411-0159)
- Product Recall: (Relating to June 2023) Bugaboo Dragonfly Seat Pushchair (2408-0168)
- Product Recall: Mazelaki Ltd Pushchair Hammock (2408-0078)
- Product Recall: Power Supply (Model: TD12200) supplied with InvoSpar Massager, JC668 sold via Amazon (2501-0125)
Section 2: medical devices 20/01/25-24/01/25
- Defibtech: Defibtech adult or pediatric defibrillation pads 17th January 2025 External defibrillation or electrode Model: DDP-100, DDP-200P, DDP-2001, DDP-2002 MHRA reference: 34483080 2025/001/007/601/052
- Exmoor: Exmoor Nasal Splints 20th January 2025 Intranasal splint, non-biodegradable Model: N6 MHRA reference: 34493173 2025/001/020/601/050
- Getinge: Heater-Cooler Unit HCU 40 High/Low Voltage 17th January 2025 Heat exchanger, Heart- Lung bypass Model: 701044054, 701054917 MHRA reference: 34516691 2025/001/023/601/005
- LivaNova: SenTiva™ VNS Therapy™ Generator 21st January 2025 Model: Model 1000, Model 1000-D MHRA reference: 34505225 2025/001/021/601/106
- LivaNova: SenTiva™ VNS Therapy™ Generator 21st January 2025 Model: Model 1000, Model 1000-D MHRA reference: 34506619 2025/001/021/601/105 – Letter 1 MHRA reference: 34506619 2025/001/021/601/105 – Letter 2
- Olympus: High Flow Insufflation Unit 19th August 2024 Laparoscopic insufflators Model: UHI-4 MHRA reference: 34488874 2024/008/014/601/059
- Psyomics: Censeo Digital 45679 Model: Version 3 MHRA reference: 34517862 2025/001/022/601/034
- RaySearch Laboratories: RayStation 17th January 2025 Various Radiotherapy Instruments – Software Model: 4.5-2024B including some service packs MHRA reference: 34483955 2025/001/017/601/016
- Spectrum Medical: Quantum Perfusion Centrifugal Blood Pump 17th January 2025 Cardiopulmonary bypass system centrifugal pump Model: Quantum Perfusion Centrifugal Blood Pump with Integrated Sensors MHRA reference: 34505600 2025/001/021/601/084
- US Endodontics: Multiple devices, see product list attached 2nd February 2020 Rotary/reciprocating endo file/rasp, single-use Model: Multiple model numbers, see product list attached MHRA reference: 34527242 2025/001/008/601/134
- Zimmer Biomet: NexGen® Legacy® Constrained Condylar Knee 23rd January 2025 Tibial insert Model: 00-5994-022-14 and 00-5994-032-10 MHRA reference: 34527012 2025/001/023/601/037
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 from FSN weekly list 23/12/24 – 27/12/24 |
| First issued19/12/24 and subsequently updated 29/01/25 | Fresenius Medical Care: 4008H, B, S, Art, Prometheus 19th December 2024 Haemodialysis system, institutional/home-use Model: M20068(1) 4008H M20011(1) 4008B M20066(1) 4008 S Standard M20067(1) 4008 S (Standard + CDS) M20084(1) 4008 S (Standard + ONLINEplus) M20085(1) 4008S (Standard + CDS + ONLINEplus) 9798931 Art Standard 9798941 Art Universal M201231 Prometheus Standard Hepa M201241 Prometheus Standard CiCa MHRA reference: 34307765 2024/012/024/601/024 – Updated FSN |
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
Tel: 0131 275 7575 | nss.iric@nhs.scot
IRIC operates incident learning and prevention systems for health and care technologies (medical devices, IVDs, estates, facilities, social care equipment and PPE). Find out more in CEL43 (2009), explore our educational content on Turas Learn or visit our website to: report an incident, find our safety alerts, or watch our short Intro to IRIC 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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