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Field Safety Notices (FSNs): 15/09/25 – 19/09/25

IRICIncident Reporting &
Investigation Centre

Manufacturers’ Field Safety Notices

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DL1 NHS Incidents and alerts Safety Officers

DL2 Local Authority Incidents and alerts Safety Officers

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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

None

Section 2: medical devices 15/09/25 – 19/09/25

  1. Abbott: TactiFlex™ Ablation Catheter, Sensor Enabled™ 45912 Cardiac radio-frequency ablation system catheter Model: Refer to FSN MHRA reference: 36769415   2025/009/012/601/033
  2. Alcon Laboratories: ULTRAVIT® and HYPERVIT® 11.09.2025 Market Action Identifier 2025.013 Vitrectomy system micro-cutting unit Model: Refer to FSN MHRA reference: 36818170   2025/009/016/601/016
  3. Baxter Healthcare SA: Sharesource Claria 45911 FA Number: FAV-2025-007 Nephrology information system software Product code: 5CGM01 Serial number: software versions 8.13.4 MHRA reference: 36757946   2025/009/009/601/021
  4. Beckman Coulter: DxC 500i Clinical Analyzer 45875 Model: Refer to FSN MHRA reference: 36833955   2025/008/004/601/040 FSN MHRA reference: 36833955   Vigilance response form
  5. Datascope Corp/Getinge: Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) 45870 Circulatory assist system, intra-aortic balloon Model: Refer to FSN MHRA reference: 36831024   2025/009/017/601/117
  6. Diagnostic Grifols S.A.: Erytra 45910 Blood group/antibody screening analyser IVD automa Product code: 210400 and 210401 Software versions: 4.5.0 and 4.6.0. MHRA reference: 36770488   2025/009/012/601/078
  7. DiaMed GmbH: ID-Anti-S, Test Serum ID-Anti-M, N, S, s, Fya, Fyb 45887 Bio-Rad Reference: FSCA-004-25 Anti-S [MNS3] red blood cell grouping IVD Model: Refer to FSN MHRA reference: 36834578   2025/008/025/601/014
  8. Epocal Inc/Siemens.: epoc BGEM BUN Test Card [25pk] 45839 epoc® Blood Analysis System Model: Refer to FSN MHRA reference: 36833855   2025/007/002/601/091
  9. ICU Medical Inc: HOTLINE HL-90 Blood & Fluid Warmer 45918 Convection blood/fluid warmer Model: HL-90-UK-230 MHRA reference: 36809273   2025/009/015/601/013
  10. Inogen, Inc.: Inogen Rove 4™ Portable Oxygen Concentrator 45901 Ref: FSN-2025-002 Model: Refer to FSN MHRA reference: 36775210   2025/009/012/601/094
  11. JRI Orthopaedics Ltd: VAIOS Humeral Stem H-AC 10mm Diameter 45909 Reference: NC592 Coated shoulder humeral stem prosthesis Model: Refer to FSN MHRA reference: 36773763   2025/009/001/601/040
  12. Maquet Cardiopulmonary/Getinge: HL 20 Heart-Lung Machine 45910 Maquet Cardiopulmonary Model: Refer to FSN MHRA reference: 36806967   2025/009/015/601/049
  13. Maquet Cardiovascular/Getinge: Heartstring III Proximal Seal System 45870 Reference Number: 1336551 Model: Refer to FSN MHRA reference: 36774157   2025/008/019/601/041
  14. Merit Medical Systems: PhD Hemostasis Valve™ 45867 FSCA Ref: 1721504-07/29/25-007R Model: Refer to FSN MHRA reference: 36823137   2025/008/006/601/044
  15. Stryker: Nasopore, Otopore 45786 RA2025-3888970 Model: Refer to FSN MHRA reference: 35729161   2025/003/020/601/047
  16. Trinity Biotech: Premier Hb9210 HbA1c Analyzer 45916 FOLLOW-UP FSN – ref INCDT001-24-3 Update to FSN dated 25 Oct 2024 – MHRA reference: 33769421  Product Code: 42790 Model: Refer to FSN MHRA reference: 36832689   2024/009/030/601/081
  17. W.L. Gore; Associates: GORE® ACUSEAL Vascular Graft 45870 Vascular Graft Model: Refer to FSN MHRA reference: 36813123   2025/008/012/601/081

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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