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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 08/01/24-12/01/24
- Corcym: Perceval Plus Sutureless Aortic Heart Valve 45289 Model: PVF-S, PVF-M, PVF-L, PVF-XL MHRA reference: 27801644
- GE HealthCare: IC9-RS Ref. # 79072 Transducer assembly, ultrasound, diagnostic, intra MHRA reference: 27801249
- Medline: Drainage bag FSN-24/01 MHRA reference: 27811181
- Molnlycke: Sternal Refractor 30x19cm 4 blades 45209 MHRA reference: 27806806
- Philips: Intera, Achieva, Ingenia CX 45288 Magnetic Resonance Imaging (MRI) unit Model: Achieva 1.5T 781196, 781343, 781296 Achieva 1.5T Conversion 781346, 781283 Achieva 1.5T Initial system 781178 Achieva 3.0T 781277, 781177, 781278, 781344, 781345 Achieva XR 781153, 781253 Ingenia 1.5T CX 781262, 781261 Ingenia 3.0T CX 781271, 782105 Intera 1.5T Achieva Nova 781172 Intera 1.5T Achieva Nova-Dual 781173 Intera Achieva 1.5T Pulsar 781171 SmartPath to dStream for 1.5T 781260, 782112 SmartPath to dStream for XR and 3.0T 781270, 782113, 782129 MHRA reference: 27806801
- SERF: Disposable cup impactor(ICJ) – NOVAE STICK 47 45280 Disposable cup impactor (ICJ) Model: RM49010002 MHRA reference: 27798737
- Stryker: Scorpio, Duracon, PCA, Trident December 2023 RA2023-3471895 MHRA reference: 27801663
- Stryker: HRIS ACET CUP CUT TIP 45261 MHRA reference: 27801254
- Therapy Equipment: Therapy Flowmeter 45281 Model: Diamond Range MHRA reference: 27798734
- Zimmer Biomet: Dermacarriers 45302 Skin graft carrier Model: 00-2195-013-00 MHRA reference: 27811681
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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