| IRIC | Incident Reporting & Investigation Centre |
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
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 Safety Report: Borg & Overstrom E4 Range Water Dispenser (2410-0018)
2. Product Recall: Xtralis and System Sensor OSID-R Conventional Detector (2409-0032)
3. Product Recall: Lakeland Dry:Soon Airer with Heater (2410-0083)
4. Product Safety Report: Battery for GTech Multi Handheld Vacuum (2312-0069)
Section 2: medical devices 21/10/24 – 25/10/24
- Abbott: Navitor™/Navitor Titan™ Transcatheter Heart Valve 45566 Transcatheter Heart Valve Model: NVRO-35, NVRO-29, NVTR-27, NVTR-29, NVRO-27 MHRA reference: 33694126 2024/010/017/601/012
- Baxter: 5C4482, R5C4482, R5C4482E, R5C4483, R5C4484 45566 Tubing set, peritoneal dialysis MHRA reference: 33686848 2024/010/022/601/029 – MOH letter MHRA reference: 33686848 2024/010/022/601/029 – Customer letter
- Baxter: HScribe, Vision Express,Q-Stress,XScribe,RScribe 23rd October 2024 Model: HScribe V4.0.0 – V4.34 MHRA reference: 33701600 2024/010/023/601/074 MHRA reference: 33701600 2024/010/023/601/074 – Letter
- GE Healthcare: Centricity Universal Viewer Zero Footprint client FMI85478 Medical Image Management System MHRA reference: 33684284 2024/010/021/601/071
- GS Elektromedizinische Geräte: Battery corpuls cpr (LiPo) 31st July 2024 Secondary Battery Model: 09120 MHRA reference: 33614772 2024/009/004/601/022
- Jenx: Ly-on 19th September 2024 MHRA reference: 33708088
- Medtronic: McGrath MAC Video Laryngoscope 45536 VIDEO LARYNGOSCOPES Model: 300-000-000, 301-000-000 MHRA reference: 33624276 2024/007/024/601/087
- Olympus: UroPass® Ureteral Access Sheath Set 4th October 2024 Dilator, Catheter Model: 61024BX, 61038BX, 61046BX, 61054BX, 61124BX, 61138BX, 61146BX, 61154BX, 61224BX, 61238BX, 61246BX, 61254BX, 61324BX, 61338BX, 61346BX, 61354BX MHRA reference: 32787869 2024/010/001/601/098
- Philips: Philips Zenition 50 & Philips Zenition 70 11th October 2024 Interventional Fluoroscopic X-Ray System Model: 718096 (Zenition 50) and 718133 (Zenition 70) MHRA reference: 33703245 2024/009/030/601/016
- SLE limited: Reusable and Single Use Flow Sensors 45587 Flow Sensors MHRA reference: 33708695 2024/009/023/601/081
- Storz: see comment 45566 MHRA reference: 33686557 2024/010/022/601/021 MHRA reference: 33686557 2024/010/022/601/021 – Covering letter
- Terumo: COBE 2991 Cell Processor System 45566 Blood Collection Tubing Set MHRA reference: 33620411 2024/010/018/601/038
- Venclose: Venclose EVSRF Catheters 18th October 2024 Refer to comments MHRA reference: 32980656 2024/009/026/601/068
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/
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.
——————————————————————————————————————————————————–