Field Safety Notices (FSNs): 05/05/25 – 09/05/25

Manufacturers’ Field Safety Notices

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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 05/05/25 – 09/05/25

1. Alcon Laboratories : Ophthalmic surgical procedure kit, non-medicated 8th May 2024 Constellation Total Plus Pak Model: See Attached MHRA reference: 35526985   2025/005/008/601/101
2. Avanos Medical Inc : Introducer Kit for Gastrostomy Feeding Tube 6th May 2025 Gastrostomy procedure kit Model: 98430; 98431; 98432; 98433; 98434 MHRA reference: 35504411   2025/005/006/601/137
3. Beckman Coulter : Sample Probe 2nd May 2025 See Section 8 MHRA reference: 35526963   2025/005/008/601/117 MHRA reference: 35526963   2025/005/008/601/117 – Vigilance response form MHRA reference: 35526963   2025/005/008/601/117 – Vigilance response form
4. Beckman Coulter Inc : Apolipoprotein B (Apo B) 1st May 2025 See Section 8 MHRA reference: 35517370   2025/005/007/601/117 – Vigilance response form MHRA reference: 35517370   2025/005/007/601/117 – Customer letter
5. Beckman Coulter: DxI 9000 Access Immunoassay Analyzer 1st May 2025 See section 8 MHRA reference: 35504362   2025/005/006/601/088
6. Beckman Coulter: DxI 9000 Access Immunoassay Analyzer 1st May 2025 See section 8 MHRA reference: 35518231   2025/005/007/601/088 – Vigilance Response Form MHRA reference: 35518231   2025/005/007/601/088 – Customer Letter UK
7. BioMérieux SA: VIDAS® TOXO Compétition 11th May 2025 Toxoplasma gondii total antibody IVD, kit, enzyme MHRA reference: 35504284   2025/005/006/601/069
8. Covidien llc: Hugo™ RAS Tower (120VAC), Hugo™ RAS Tower (240VAC) 45748 ROBOT-ASSISTED ENDOSCOPIC SURGERY SYSTEMS MHRA reference: 35442350   2025/004/029/601/068
9. ICU Medical Inc: CADD-Solis™ Ambulatory Infusion Pumps 9th May 2025 Bedside infusion pump, single-channel Model: See FSN MHRA reference: 35503251   2025/005/006/601/043 – Letter MHRA reference: 35503251   2025/005/006/601/043   
10. ICU Medical Inc : CADD-Solis™ Ambulatory Infusion Pumps 9th May 2025 Bedside infusion pump, single-channel Model: See FSN MHRA reference: 35504833   2025/005/006/601/044
11. ICU Medical Inc: CADD-Solis™ Ambulatory Infusion Pumps 9th May 2025 Bedside infusion pump, single-channel Model: See FSN MHRA reference: 35503450   2025/005/006/601/042 – Letter MHRA reference: 35503450   2025/005/006/601/042
12. Medical Innovation Developpment : MID-TUBE 27th March 2025 MHRA reference: 35503992   2025/005/007/601/009
13. Medtronic MINIMED : Simplera™ sensors 45778 MHRA reference: 35517712   2025/005/007/601/023 MHRA reference: 35517712   2025/005/007/601/023 – HCP letter MHRA reference: 35517712   2025/005/007/601/023 – HCP courtesy letter
14. Medtronic Navigation Inc: StealthStationTM Cranial and SynergyTM Cranial 45261 Neurological stereotactic surgery system Model: 9735585, 9735586, 9735587 MHRA reference: 35518550 MHRA reference: 35518550 – Customer Acknowledgement Form
15. Natus Medical Incorporated DBA Excel-Tech Ltd : Olympic Brainz Monitor (Digital Acquisition Box) FCA#000057 Model: OBM00002 MHRA reference: 35495461   2025/005/002/601/075 – Customer letter
16. SkylineDx BV: Merlin Assay (incl. software MAAS) 45775 MHRA reference: 35517900   2025/005/006/601/132

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 List of Field Safety Notices from 28 October to 1 November 2024

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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