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Field Safety Notices (FSNs): 04/08/25 – 08/08/25

IRICIncident Reporting &
Investigation Centre

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 Safety Report: Cochran Ltd Ultranox Boiler Burner (2507-0072)

Section 2: medical devices 04/08/25 – 08/08/25

  1. Baxter Healthcare: PrisMax Systems and TherMax Blood Warmer Units 45870 FA Number: FAV-2025-005 Model: 955515, 955725, 955558 MHRA reference: 36372260   2025/007/029/601/054
  2. BD Switzerland: BD Alaris™ Plus and Alaris™ neXus Syringe Pumps 45868 Syringe pump Model: Refer to FSN MHRA reference: 36368613   2025/007/025/601/092
  3. CareDx Pty Ltd: AlloSeq cfDNA Software 45876 Cell-free DNA analysis interpretive software IVD Model: IFU091_AlloSeq cfDNA Software IFU – CE MHRA reference: 36399138   2025/008/007/601/031
  4. Fresenius Kabi: Agilia VP MC WIFI 45866 Ref: ECMD202511 version 01 Product code: Z019730 MHRA reference: 36372133   2025/007/021/601/054
  5. Haemoband Surgical Ltd: HB-SleeveLUX Proctoscope 45870 Ref: FSN-2025-01 Shelf-life extension Affected batches: Lot PS2400000 MHRA reference: 36359166   2025/008/001/601/098 – Acknowledgement form MHRA reference: 36359166   2025/008/001/601/098 – FSN
  6. Max Mobility LLC: SpeedControl Dial utilized with SmartDrive MX2+ Power Assist Device 45866 Ref. FSCA CAPA 25-007 Manual wheelchair, power assist unit Model: Refer to FSN MHRA reference: 36354122   FSCA077-2025
  7. Philips: Allura Xper systems 45869 Philips Reference: 2024-IGT-BST-014 Stationary angiographic x-ray system, digital Model: Refer to FSN MHRA reference: 36371739   2025/008/004/601/016
  8. Philips Medical Systems: Pinnacle³ Radiation Therapy Planning System 45870 Philips Reference # 2025-EI-TPS-002 Radiation therapy software Model: Refer to FSN MHRA reference: 36381204
  9. RaySearch Laboratories AB: RayStation/RayPlan Medical Device Correction #161525 Various Radiotherapy Instrument – Software Model: Refer to FSN MHRA reference: 36401149   2025/008/007/601/052
  10. SCHILLER AG: ARGUS PB-3000 45877 FSCA Ref: SAGQI-2335 Vital Signs Monitoring Instruments Model: Refer to FSN MHRA reference: 36402609   2025/008/007/601/060
  11. Tracoe medical GmbH: Tracoe Vario Tracheostomy Tube REF 470-08 45863 Cannula Model: Refer to FSN MHRA reference: 36398862   2025/008/001/601/020
  12. Vygon (UK) Ltd: Easymoov6 Enteral Feeding Pump 45839 FSN Ref: 2507/51788/00 – PM6/SS14/FSN Enteral feeding pump Model: 0VEPM6G02 MHRA reference: 36371973   2025/007/002/601/101
  13. Welland Medical Ltd: Aura 45873 FSN Ref: 2025-07-29/3209 Ostomy pouch Batches: VM07083 Model: MHDM513-30-GB1 MHRA reference: 36391381   2025/007/029/601/053 – User letter MHRA reference: 36391381   2025/007/029/601/053 – Wholesaler letter

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 summaryChange(s) made
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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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