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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 12/06/23 – 19/06/23
- Beckman Coulter: DxA 5000 Automation System 45089 Specimen processing instrument IVD, automated MHRA reference: 5323189
- bioMérieux: MYLA V4.8 SOFTWARE; MYLA V4.9 SOFTWARE 44972 Laboratory instrument/analyser application software MHRA reference: 5319742
- HS DOMS GmbH: HS 810 45013 MHRA reference: 5314023
- Integra: Surgimend / Primatrix 45076 Extra-gynaecological surgical mesh/Collagen Matrix MHRA reference: 5302965
- Intuitive: Tip-Up Fenestrated Grasper ISIFA2023-02-R Robotic surgical forceps Model: 470347-12 MHRA reference: 5314523
- Medtronic: Durepair Dura Regeneration Matrix 45078 Dura mater graft, bovine Model: 61100, 61105, 61106, 61110, 61111 MHRA reference: 5319571
- OLYMPUS: HF-resection electrode 45093 Electrodes, Electrosurgical MHRA reference: 5321616
- QIAGEN: NeuMoDx Cartridge 45047 MHRA reference: 5314266
- Randox: Urea Enzymatic Kinetic Assay 45086 Urea IVD, kit, enzyme spectrophotometry MHRA reference: 5314857
- Samsung: GM85 FSN-GM85_230228-1 Mobile Digital Batteries X-ray Units MHRA reference: 5295225
- Siemens: Cios Select 45047 Mobile X-ray system intended for angiography Model: 11515088 MHRA reference: 5317142
- Stryker: AIRO CT SCANNER 45078 MHRA reference: 5317111
- Talley: Venturi QRN1006 Negative pressure wound therapy system Model: Venturi Compact and Venturi MiNO MHRA reference: 5323149
- Tosoh: GX Assay Kit 45049 BUFFERS (UNASSIGNABLE), SUPPLEM. REAG MHRA reference: 5203495
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.
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/
Incident Reporting & Investigation Centre (IRIC)
Health Facilities Scotland
NHS National Services Scotland
Tel: 0131 275 7575|nss.iric@nhs.scot | Report an incident | Find safety alerts
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 about our services at www.nss.nhs.scot
FAC406-015, 8B(i), Rev 6