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Manufacturers’ Field Safety Notices
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List of FSNs covering the period 30 Oct to 3 Nov, published by MHRA on 17 November and circulated by IRIC on 17 November
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 30/10/23 – 03/11/23
- Abbott: Alinity s System 45218 Chemiluminescent immunoassay analyser IVD MHRA reference: 27512962
- Abbott: Alinity m HCV AMP Kit 45229 Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT) MHRA reference: 27520217
- Baxter: EVO IQ Syringe Pump 45216 Model: ESYR001GRC (non UK) and ESYR001UKI (UK) MHRA reference: 27512180
- Beckman Coulter: Access 2 Immunoassay Analyzer (81600N); Access 2 Immunoassay Analyzer, Refurbished (386220); Access 2 Immunoassay Analyzer-Refurbished (A65531); and Access 2 Section, DxC 600i Packaged (A25640) 44956 Chemiluminescent immunoassay analyser IVD MHRA reference: 5143098
- bioMérieux: BCID2 Panel 45232 Multiple bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Model: RFIT-ASY-0147 MHRA reference: 27515932
- Eitan Medical: Sapphire Multi-Therapy and Sapphire Epidural 45181 MHRA reference: 27515954
- Elekta: Unity 45078 SINGLE ENERGY LINEAR ACCELERATORS Model: 1553106 MHRA reference: 27512490 update to 5145650
- Medtronic: HVAD Pump Implant Kit October 2023 FA1372 Implantable Ventricular Circulatory Assist System MHRA reference: 27516083
- Philips: Allura Xper, Allura Centron, and Azurion systems 45153 Interventional Fluoroscopic X-Ray System Model: 708032, 708034, 708036, 708037, 708038, 722001, 722002, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722015, 722019, 722020, 722022, 722023, 722025, 722026, 722027, 722028, 722029, 722031, 722033, 722035, 722038, 722039, 722058, 722059, 722063, 722064, 722065, 722066, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228, 722280, 722400 MHRA reference: 27515072
- Philips: MD Eleva systems 45153 Interventional Fluoroscopic X-Ray System Model: 708032, 708034, 708036, 708037, 708038, 722001, 722002, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722015, 722019, 722020, 722022, 722023, 722025, 722026, 722027, 722028, 722029, 722031, 722033, 722035, 722038, 722039, 722058, 722059, 722063, 722064, 722065, 722066, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228, 722280, 722400 MHRA reference: 27515072
- Philips: Intera, Achieva, Ingenia CX 45222 Magnetic Resonance Imaging (MRI) unit Model: 781105, 781195, 781295, 781178, 781196, 781296, 781343, 781283, 781346, 781261, 781262, 781260, 782112 MHRA reference: 27503910
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)
Facilities Division
NHSScotland Assure
NHS National Services Scotland
Tel: 0131 275 7575|nss.iric@nhs.scot | Report an incident | Find safety alerts | IRIC | Turas Learn
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
FAC406-212, 8B(i), Rev 6
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