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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
- Product Recall: Cavius 4002 / CV4002 Carbon Monoxide Alarm (2403-0152)
- Product Recall: Bluzen Deluxe Heating Pad sold by TK Maxx (2404-0002)
Section 2: medical devices 01/04/24 – 05/04/24
- Abbott: Aveir VR Leadless Pacemaker 45383 Intracardiac pacemaker Model: LSP112V MHRA reference: 29240940
- Cook: EchoTip Ultra Endoscopic Ultrasound Needle 45383 Model: ECHO-19 MHRA reference: 29239345 FSN MHRA reference: 29239345 Reply form
- Green Power: Rechargeable lithium battery pack 45352 MHRA reference: 29242630
- Innuovo: Power Wheelchair 45378 Model: W5521 MHRA reference: 29240916
- KARL STORZ: 8694 – LASER Application Instrument, 23 cm, 461000 – LEUNIG-GREVERS LASER Application 45377 Rigid endoscope working guide MHRA reference: 29228773
- Leica Microsystems: M530 OHX, PROvido, Proveo 8 45170 microscope, surgical, general purpose MHRA reference: 29233321
- Medtronic: HVAD Pump Implant Kit 45386 MHRA reference: 29243508
- natus: BRAIN QUICK SOFTWARE 45371 MHRA reference: 29231548
- RaySearch Laboratories: RayStation 45379 Various Radiotherapy Instruments – Software Model: 7-2024A including some service packs MHRA reference: 29225345
- Smiths Medical: Cardinal Health Branded Monoject Syringe 45390 Bedside infusion pump, single-channel MHRA reference: 29242780
- Swemac: Motec Wrist Radius Hemi Prosthesis TIC02537 Partial wrist radius prosthesis MHRA reference: 29244802
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 summary | Change(s) made |
| None | n/a |
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 7
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