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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 02 to 06 September 2024
- Miltenyi Biotec B.V. & Co. KG: LIFE 21 apheresis unit 30.08.2024 Apheresis System 330-000-621, 330-000-622 MHRA reference: 31738772 2024/008/030/601/071
- JRI Orthopaedics Ltd: AVANTEON® Stem Inserter 45497 Orthopaedic implant inserter/extractor, reusable Catalogue: 007006 LOT: 106255 MHRA reference: 31738843 2024/007/019/601/020
- Waldemar Link GmbH: Universal Handle, Stainless Steel, straight 02.09.2024 Surgical instrument handle, non-torque-limiting Model: 130-394/01 MHRA reference: 31750110 2024/009/002/601/071 MHRA reference: 31750110 – Reply form
- Fresenius Medical Care: multiFiltratePRO Machine 19.08.2024 Mandatory Software Update Haemodialysis system, institutional/home-use Model: M205001 Software version: Software versions 6.02 and 5.02 MHRA reference: 31755107 2024/005/020/601/024
- GE Healthcare: Centricity High Acuity Anesthesia 03.09.2024 Patient health record information system Model: Software version 5.8 and above MHRA reference: 31754166 2024/006/028/601/045
- Becton Dickinson: Guidewire 70cm x 1mm (0.038”) 45506 Cardiac/peripheral vascular guidewire, single-use Model: Refer to FSN MHRA reference: 31752646 2024/007/030/601/057
- Stryker: iBur™ Distal Bend Cutting Accessories 45474 Precision Round, Distal Bend Model: Appendix A in the attached Field Safety Notice MHRA reference: 31762188 2024/007/031/601/083
- Smiths Medical: CADD Medication Cassette Reservoir 45540 Model: Refer to FSN MHRA reference: 31747982 2024/009/002/601/020
- Schiller Medical: DEFIGARD Touch7 monitor and defibrillator 45444 Monitor Defibrillator Model: All DEFIGARD Touch7 devices MHRA reference: 31740373 2024/006/028/601/011
- Olympus: High Flow Insufflation Unit 21st March 2023 Laparoscopic insufflators Model: UHI-4 MHRA reference: 31672021 2024/003/018/601/076
- JRI Orthopaedics Ltd: Furlong Evolution Trial Necks 45441 Femoral Stem Prosthesis Trial Model: Refer to FSN MHRA reference: 31779920 2024/005/028/601/065
- GE Healthcare: Aisys CS2 , Avance CS2 , Avance CS2 Pro, Aisys, Avance, Amingo, Aespire 100, Aespire View, Aespire 7900, and Aespire 7100 anesthesia devices equipped with the Auxiliary Common Gas Outlet (ACGO) 45534 Anaesthesia system Model: Refer to FSN MHRA reference: 31779707 2024/008/002/601/040
- Intersurgical Ltd: IPPB Flextube™ breathing system 04.09.2024 Ventilator breathing circuit, single-use Model: 1415000, 1415002, 1416000 MHRA reference: 31775757 2024/009/004/601/080
- Hologic, Inc.: Selenia Dimensions / 3Dimensions 45530 X-ray system, Diagnostic, Mammographic, Stationary Model: Refer to FSN MHRA reference: 31765694
- Bohus BioTech AB: Minivisc® Plus 45533 Eye Lubricant Model: MPFX16100 and MPFX17100 MHRA reference: 31738826 2024/008/030/601/022
- Agfa NV: DR 800 06.08.2024 Digital Radiography X-ray System DR 800 Model: 6010/200 MHRA reference: 31732211 – Completion date: (15 October 2024)
- Agfa NV: DR 800 06.08.2024 Digital Radiography X-ray System DR 800 Model: 6010/200 MHRA reference: 31732211 – Completion date: (15 April 2025)
- Randox Laboratories Ltd: Randox HbA1c Calibrator Set 04th September 2024 Glycated Haemoglobin (HbA1c) IVD, calibrator Model: 623672, 637478 MHRA reference: 31795803
- Kinova Inc.: Kinova Jaco assistive robotic arm 26.08.2024 Assistive dynamic arm support system Model: PJ 0000 0001, PJ 0000 0012, PJ 0090 0001, PJ 0090 0006, KR MJ2 0001 MHRA reference: 31801360 2024/008/012/601/041
- Becton Dickinson: BD FACSDuet™ Sample Preparation Systems 45517 AUTOSAMPLERS Model: Refer to FSN MHRA reference: 31795715 2024/008/007/601/066
- Boston Scientific: AVVIGO+ Multi-Modality Guidance System 45540 Ultrasound System, Imaging, Cardiovascular Model: Refer to FSN MHRA reference: 31795673 2024/009/005/601/077
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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