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Manufacturers’ Field Safety Notices
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DL3 Specialist Liaison Group
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Outlook tags IRICSW$i0 (safety alert – general), IRICSW$i5 (field safety notices)
Please be aware this FSNs list covers the previously missing date range 19/05/25 – 23/05/25 advised on Tuesday this week.
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
None
Section 2: medical devices 19/05/25 – 23/05/25
- Bard Access Systems: Refer to FSN 15th May 2025 Peripherally-inserted central venous catheter MHRA reference: 35612425 2024/010/028/601/056 MHRA reference: 35612425 2024/010/028/601/056 – Attachment 1
- BD Switzerland Sàrl : Refer to FSN 13th May 2025 See comments MHRA reference: 35659729
- Beckman Coulter: DxI 9000 Access Immunoassay Analyzer 13th May 2025 See Section 8 MHRA reference: 35636707 2025/005/019/601/065
- CareDx Pty Ltd : AlloSeq cfDNA 22nd May 2025 MHRA reference: 35672441 2025/005/022/601/053
- Change Healthcare: CHC Hemodynamics 23rd May 2025 Cardiac Catheterization laboratory computer Model: 15.0.1,15.1.1 MHRA reference: 35649227 2025/005/020/601/120
- Covidien llc : Newport HT and HT70™ Plus Ventilators 45778 Neonatal/adult intensive-care ventilator Model: HT70PM-WW-NA, HT70PM-SY-EU, HT70PM-SY-NA, HT70PM-SY-UK, HT70PM-ES-EU, HT70PM-ES-NA, HT70PM-JP-NA, HT70PM-PT-BR HT70PM-WW-EU HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR, HT70M-SY-EU, HT70M-WW-EU, HT70M-WW-NA, HT70-SY-EU, HT70PM-SY-AS, DLHT70PM-WW-NA, HT70PM-WW-EU, HT70PM-WW-UK MHRA reference: 35658497 2025/005/021/601/034 MHRA reference: 35658497 2025/005/021/601/034 – Attachment A MHRA reference: 35658497 2025/005/021/601/034 – Attachment B
- Covidien llc: Microstream Advance and Luer Sampling Lines 45778 Class I: R9099, Class IIa: R03010204, R9099 MHRA reference: 35651933 2025/002/019/601/080
- Drägerwerk AG : SafeStar Plus, TwinStar HEPA Plus 45778 Filter, Ventilator Model: multiple (refer to FSN) MHRA reference: 35649623 2025/005/020/601/072
- Exmoor Plastics: Exmoor Suction Clearance Kits 20th May 2025 Secretion Suction Kit Model: SC6 SC4JH MHRA reference: 35659311 2025/005/021/601/009
- GE Healthcare Finland Oy : Centricity High Acuity Anesthesia / Critical Care FMI 38017 Patient health record information system MHRA reference: 35637011 2025/005/019/601/012
- Maco Pharma : Whole Blood Collection Sets 21st May 2025 Model: LQT614B, FQE614B, NPT610A, LQT6287LU MHRA reference: 35657996 2025/005/020/601/027
- Maco Pharma: LQT, NPT, NQT 22nd May 2025 In-Line Red Cell Filtration System Model: LQT710X, NPT610A, NQT614B, LQT613U MHRA reference: 35671319 2025/005/021/601/023
- Quantum Surgical: EPIONE device 16th May 2025 Robotic surgical navigation system Model: 30-0001 MHRA reference: 35608489 2025/005/016/601/025
- RaySearch Laboratories: RayStation 13th May 2025 Various Radiotherapy Instruments – Software Model: 2024B MHRA reference: 35613828 2025/005/016/601/050
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
| 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
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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