Field Safety Notices (FSNs): 17/03/25 – 21/03/25

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

1.     Product Recall: Petzl Swan Easyfit Climbing Harnesses (2503-0087)

2.     Product Recall: Petzl Newton Climbing Harnesses (2503-0086)

3.     Product Recall: Elbow Grease Heavy Duty Hand Cleaner (2503-0036)

4.     Child safety: baby sleep products / OPSS is leading a fresh campaign to raise awareness about potential hazards to babies associated with sleep products.

Section 2: medical devices 17/03/25 – 21/03/25

1. Arthrex INC: OATS® 2.0 Single-Use Set, 12 mm R545 Orthopaedic osteotome Model: ABS-8981-12S  MHRA reference: 35005107   2024/011/008/601/055
2. Beckman Coulter: DxC 500i Clinical Analyzer 7th March 2025 See section 8 MHRA reference: 35005098   2025/003/014/601/032 MHRA reference: 35005098   2025/003/014/601/032 – Vigilance response form
3. Beckman Coulter: DxC 500i Clinical Analyzer 13th March 2025 See Section 8 MHRA reference: 35028594   2025/003/018/601/085 MHRA reference: 35028594   2025/003/018/601/085 – Vigilance response form
4. Caesarea Medical Electronics Limited: BodyGuardTM MultiPurpose Infusion Pump System 11th September 2024 Ambulatory non-insulin infusion pump, electronic MHRA reference: 34870431  2025/002/026/601/022
5. Canon Medical Systems Corporation: Vantage Orian, Vantage Elan, Vantage Titan 14th March 2025 Full-body MRI system, superconducting magnet Model: MRT-1550, MRT-2020, MRT-1504, MRT-2004 MHRA reference: 35014991   2025/003/014/601/090
6. Covidien llc: Hugo™ RAS Arm Cart Assembly 45717 MHRA reference: 35046359   2025/001/027/601/065
7. GE Healthcare: Please see section 8 Comments FMI 85480 MHRA reference: 35040388   2025/003/019/601/023
8. GE Medical Systems LLC : Revolution CT and Revolution Apex series FMI 25504 Full-body CT system MHRA reference: 35025644   2025/003/014/601/077
9. ICU Medical Inc: ProPort™ Plastic Implantable Ports 27th February 2025 Spinal port/catheter Model: See FSN MHRA reference: 35018979   2025/002/024/601/026
10. Medtronic Limited: Evolut PRO+, Evolut FX, Evolut FX+ Systems 45717 Transcatheter Aortic Valve Model: EVPROPLUS-23, EVPROPLUS-26, EVPROPLUS-29, EVPROPLUS-34, EVOLUTFX-23, EVOLUTFX-26, EVOLUTFX-29, EVOLUTFX-34, EVFXPLUS-23, EVFXPLUS-26, EVFXPLUS-29, EVFXPLUS-34 MHRA reference: 35044823   2025/003/019/601/037
11. PendraCare International B.V: CLIMBER FSCA 25-001 Vascular Guide Catheter Model: EBU 3.5 MHRA reference: 35042141   2025/002/025/601/045 – Letter
12. PFM medical: Kölner Drainage; Redon Bottle 30th March 2023 Manual wound suction syst; Closed-wound drainage  MHRA reference: 35005209   2023/004/011/601/007
13. Philips Medical Systems: Philips Allura and Azurion 13th January 2025 Interventional Fluoroscopic X-Ray System Model: 722031722003722010722026722005 MHRA reference: 35026809  2025/001/015/601/013
14. Radiometer Medical ApS : ABL90 FLEX and ABL90 FLEX PLUS Analyzer 11th March 2025 See section 8 Model: 393-090, 393-092 MHRA reference: 35056560 – Letter
15. Siemens Healthcare Diagnostics Inc: Atellica CH Revised C-Reactive Protein (RCRP) 45717 See comments Model: N/A MHRA reference: 35042868   2025/003/013/601/080
16. Thoratec Corporation: HeartMate 3 Mobile Power Unit (MPU) 45717 Heart Ventricle Prosthesis Model: 107758, 107758UK, L107758 MHRA reference: 35006306   2025/003/013/601/040
17. Thoratec Corporation: HeartMate 3 Mobile Power Unit (MPU) 45717 Heart Ventricle Prosthesis Model: 107758, 107758UK, L107758  MHRA reference: 35006368   2025/003/013/601/040 – Letter
18. Wright Medical Technology Inc: TENDON SPACER (SWANSON/HUNTER) 24CM X 3MM FLEXSPAN RA2024-3843283 MHRA reference: 35006173   2025/001/021/601/030

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)

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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