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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 26/08/24 – 30/08/24
- Abbott: Alinity i HBsAg Controls, ARCHITECT HBsAg Controls 26th August 2024 Hepatitis B virus surface antigen IVD, control MHRA reference: 31684075
- DeVilbiss Healthcare: Samsoft 6th August 2024 Model: Samsift 150 & Samsoft 175 MHRA reference: 31683684
- GE Healthcare: Giraffe Warmer, Panda iRes Warmer FMI 32095 Warmer, radiant, infant MHRA reference: 31708631
- Leica: Leica Biosystems Cryostats 27th August 2024 Cryostat microtome IVD Model: see attachment 1 MHRA reference: 31708503
- Medtronic: Software App 9735762 Stealth S8 Application 45505 Stereotactic surgery system, multi-purpose Model: 9735762 MHRA reference: 31724563
- Phillips: Philips Azurion System 6th August 2024 Stationary general-purpose fluoroscopic x-ray Model: 722079, 722224 MHRA reference: 31708580
- Siemens Healthineers : Reference Section 8 45505 Reference Section 8 MHRA reference: 31616238
- Siemens Healthineers : ACUSON Redwood Diagnostic Ultrasound System US021/24/S + US027 – 28/24/S + US034/24/S General-purpose ultrasound imaging system Model: 11503314 MHRA reference: 31554675
- Technomed: Disposable Stimulating Dissectors; Neurosign brand 25th July 2024 Nerve-locating probe – single use Model: 4013-00; 5888-00 MHRA reference: 31519256
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 |
| n/a | 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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