Field Safety Notices (FSNs): 07/07/25 – 11/07/25

Manufacturers’ Field Safety Notices

Circulation

DL1 NHS Incidents and alerts Safety Officers

DL2 Local Authority Incidents and alerts Safety Officers

DL3 Specialist Liaison Group

DL4 Product Specialists

DL5 General list (internal)

DL7 General list (external)

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

1.    Product Recall: John Lewis & Partners Carnival Floor Cushion (2507-0004)

Section 2: medical devices 07/07/25 – 11/07/25

1. Baxter Healthcare SA : Sharesource Adequest 45839 Nephrology information system software MHRA reference: 36119293   2025/007/008/601/027 MHRA reference: 36119293   2025/007/008/601/027 – Letter
2. Boston Scientific Corporation : Carotid WALLSTENT™ Monorail Endoprosthesis 45845 MHRA reference: 36081820   2025/007/007/601/066
3. Boston Scientific Neuromodulation Corporation: SureTek Burr Hole Cover Kit 45847 Deep brain electrical stimulation system MHRA reference: 36081583   2025/007/007/601/085
4. Microgenics Corporation : CEDIA Amphetamine Oral Fluid Testing (OFT) Assay 45833 MHRA reference: 36101731   2025/007/001/601/125
5. Osstell AB : Osstell SmartPeg 45838 Type 101, 102, 103 & 104 MHRA reference: 36110623   2025/007/009/601/089
6. Perouse Medical : POLYPERF 45847 Needle, subcutaneous injection/infusion port MHRA reference: 36110499   2025/007/009/601/036 MHRA reference: 36110499   2025/007/009/601/036 – Customer reply form
7. Philips Medical Systems Nederland B.V: See Model number 45838 Magnetic Resonance Imaging (MRI) unit Model: Achieva 3.0T – 781177, 781277, 781278, 781344, 781345, Achieva XR – 781153, 781253 Evolution upgrade 1.5T – 782116, 782148 Evolution upgrade 3.0T – 782117, 782143 Ingenia 1.5T – 781315, 781341, 781396, 782101, 782115, 782140 Ingenia 1.5T S – 781347 Ingenia 3.0T – 781342, 781377, 782103 Ingenia 3.0T CX – 781271, 782105 Ingenia Ambition S – 781359, 782108, 782133, 782139 Ingenia Ambition X – 781356, 782109, 782138 Ingenia Elition S – 781357, 782106, 782137, 782150 Ingenia Elition X – 781358, 782107, 782119, 782136, 782151 Intera 3.0T Quasar Dual – 781150 MR 5300 – 782110, 782135, 782152 MR 7700 – 782120, 782153 SmartPath to dStream for 3.0T – 782145, SmartPath to dStream for XR and 3.0T – 781270, 782113, 782129 SmartPath to Ingenia Elition X – 782118, 782144 Upgrade to MR 7700 – 782130 MHRA reference: 36036261   2025/007/001/601/098
8. Stryker : UNIVERSAL JOINT SCREWDRIVER 45717 MHRA reference: 36040370   2025/004/003/601/030

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

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/  

Kind regards

Incident Reporting & Investigation Centre (IRIC)

NHSScotland Assure

NHS National Services Scotland

Tel: 0131 275 7575 | nss.iric@nhs.scot 

IRIC operates incident learning and prevention systems for health and care technologies (medical devices, IVDs, estates, facilities, social care equipment and PPE). Find out more in CEL43 (2009), explore our educational content on Turas Learn or visit our website to: report an incident, find our safety alerts, or watch our short Intro to IRIC video

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 in our NSS Strategic Framework 2024-2026

FAC406-212, 8B(i), Rev 7

——————————————————————————————————————————————————–
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.

——————————————————————————————————————————————————–