| IRIC | Incident Reporting & Investigation Centre |
Manufacturers’ Field Safety Notices
Circulation
NHS incidents and alerts safety officer
Local authority incidents and alerts safety officers
IRIC product specialists
IRIC alerts general list
Specialist liaison list
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 11/09/23 – 15/09/23
- Accuray: Radixact Treatment Delivery System 45126 MHRA reference: 27349139
- Hamilton Medical: HAMILTON-C1/HAMILTON-T1/HAMILTON-MR1 45133 MHRA reference: 27371696
- iMDsoft: MetaVision Ref MCR #151-2; MDSS ref. UKV23.031 Information system software, application program Model: MetaVision 6 MHRA reference: 27371883
- Laborie: injeTAK Adjustable Tip Needle 45027 General-purpose endoscopic needle, single-use Model: DIS199, DIS201 MHRA reference: 27373741
- LINK: OptiStem Rasp Handle Stainless Steel 45131 Rasp Handle Model: 17-5220/01 MHRA reference: 27349180
- Philips: CombiDiagnost R90, ProxiDiagnost N90 44958 X-ray system, diagnostic, fluoroscopic Model: 709030, 709031; 706100, 706110 MHRA reference: 27371711
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
FAC406-015, 8B(i), Rev 6
——————————————————————————————————————————————————–
This email is intended for the named recipient only. If you have received it by mistake,
please (i) contact the sender by email reply; (ii) delete the email from your system; .
and (iii) do not copy the email or disclose its contents to anyone.