Field Safety Notices (FSNs): 19/08/24 – 23/08/24

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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

1. Product Recall: ElectriQ CD10L Dehumidifier (2408-0029)

2. Product Recall: Cuggl Infant Carrier Car Seat with Isofix base sold by Argos (2408-0096)

3. Product Recall: TU Children’s Sleepsuits (2408-0098)

4. Product Recall: iCandy Orange 4 Pushchair (2408-0128)

5. Product Recall: ByKallevig EOCH Office Chair in Black and Brown (2311-0025 / 2311-0026)

6. Product Recall: Fantasy Wireless charging pad supplied with a Royal National Institute of Blind People (RNIB) branded accord player (2406-0131)

Section 2: medical devices 19/08/24 – 23/08/24

Getinge: Custom Tubing Set – See Annex I 45519 Tubing set, heart-lung bypass Model: See Annex I MHRA reference: 31543898 2024/008/019/601/004
Fisher & Paykel Healthcare: Airvo 3 NIV 45505 Professional high-flow respiratory unit, humidify Model: PT311XX First manufacturing date: 17 March 2021; Last manufacturing date: 14 March 2024 Software version: 1.5.1 or earlier MHRA reference: 31529707 2024/008/015/601/035
ThermoFisher Scientific: Cholesterol 05.06.2024 Total cholesterol lipid IVD, kit, enzyme spectroph Catalog Number: 981813 Lot Number: WB28, WA26 MHRA reference: 31554738 – Letter 2024/006/006/601/020 MHRA reference: 31554738 – Distributor response form MHRA reference: 31554738 – Response form
Siemens: Atellica IM and ADVIA Centaur Erythropoietin (EPO) 45316 Model: Refer to FSN MHRA reference: 31566323 2024/001/025/601/052 MHRA reference: 31566323 – Response letter
Siemens: Sensis, Sensis Vibe Hemo, Sensis Vibe Combo 44866 Cardiac catheterization laboratory computer Serial number: Sensis/Sensis Vibe systems with software version VD12A MHRA reference: 31566604 2023/010/027/601/011
Siemens: Cios Alpha VA30, Cios Spin VA30, Cios Flow VA30 45170 Portable general-purpose fluoroscopic x-ray system Serial number: Cios systems with software version VA30A MHRA reference: 31566552 2023/009/012/601/061
Medtronic: Vanta™ Implantable Neurostimulator (INS) 45505 Vanta with AdaptiveStim Technology Model: 977006 MHRA reference: 31566524 2024/008/020/601/021
Medtronic: McGrath MAC Video Laryngoscope 45474 VIDEO LARYNGOSCOPES Model: 300-000-000, 301-000-000 MHRA reference: 31554799 – Letter 2024/007/024/601/087 MHRA reference: 31554799 – Customer Acknowledgement form
Drive DeVilbiss Healthcare Ltd: SAMSOFT 175 and Mini SAMSOFT 150 45510 Samsoft Model: SAMSOFT 175 (SN < 90760371) and any serial No. starting with the letter D and Mini SAMSOFT 150 (SN < 90760431) MHRA reference: 31566414 2024/008/020/601/060
Siemens: Atellica CI, Atellica IM and ADVIA Centaur CA 19-9 45474 Model: Refer to FSN MHRA reference: 31560996 2024/007/031/601/074 MHRA reference: 31560996 – Customer letter
Siemens: Atellica CH Analyzer, Atellica CI Analyzer 45364 Atellica CH Iron3 – Iron IVD, kit, spectrophotometry Model: Refer to FSN MHRA reference: 31565659 2024/003/018/601/016 MHRA reference: 31565659 – Customer letter
Medtronic: NIM Contact™ and NIM™ Standard EMG Reinforced Endotracheal Tubes 45474 EMG TUBE REINFORCED Model: Refer to FSN MHRA reference: 31563916 2022/005/017/613/002
Abbott: Alinity m System 45370 List Numbers: 08N53-002 MHRA reference: 31562491 2024/003/021/601/058
Siemens: IMMULITE 2000 Analyzer and IMMULITE 2000 XPi Analyzer 45383 Thyroglobulin antibody IVD, kit, chemiluminescent Model: Refer to FSN MHRA reference: 31562470 2024/004/026/601/067
Medtronic: NIM Vital™ Nerve Monitoring System 45444 Nerve-locating system Model: NIM4CM01: NIM Vital™ Console NIM4CPB1: NIM Vital™ Patient Interface 4 Channel MHRA reference: 31562099 2024/006/028/601/021
Medtronic: Ascenda™ Intrathecal catheters 45413 Design update to Ascenda™ Intrathecal catheters Model: 8780, 8781, and 8784 MHRA reference: 31561682 2024/005/013/601/004
Siemens: ACUSON Juniper and ACUSON Maple Ultrasound systems 45511 General-purpose ultrasound imaging system Model: 11335791 MHRA reference: 31561592 2024/008/020/601/024
Boston Scientific: ISLEEVE™ Expandable Introducer Set 45342 Vascular Catheter Introduction Set Model: H74939349140 MHRA reference: 31560930 2024/002/020/601/033
Leonhard Lang GmbH: GS Corpuls defibrillation electrodes 45481 Defibrillation electrodes Model: REF 04324.3 corPatch easy; REF 05120.1 corPatch easy pre-connected; REF 05120.3 corPatch easy pedriatic MHRA reference: 31554930 2024/007/017/601/031
Siemens: Atellica® UAS 800 Urine Sediment Analyzer, Atellica® 1500 Automated Urinalysis System 45292 Urine analyser IVD, laboratory, automated Model: All versions up to and including v4.0.400 MHRA reference: 31554888 2024/001/031/601/043 MHRA reference: 31554888 – Customer letter
Medtronic: StealthStation™ S8 App 45383 Stereotactic surgery system, multi-purpose Model: 9735762 Version number: 1.0.1, 1.0.2, 1.0.3, 1.1.0 and 1.2.0. MHRA reference: 31554817 2024/004/017/601/022
Abbott: Alinity hq Analyzer 45457 Haematological cell analyser IVD, automated Model: 09P68-01 Software version 5.6 and below MHRA reference: 31564847 2024/006/018/601/023
Alcon: DAILIES TOTAL1®, TOTAL30® 45519 Soft contact lens Model: Attachment 1 MHRA reference: 31583112 2024/008/012/601/038 MHRA reference: 31583112 – Customer letter
Siemens: ADVIA® 1800, ADVIA® 2400 and ADVIA® Chemistry XPT Systems 45505 Microalbumin IVD, kit, nephelometry/turbidimetry Model: Refer to FSN MHRA reference: 31584267 2024/008/021/601/054 MHRA reference: 31584267 – Customer letter
Change Healthcare Canada Company: Change Healthcare Cardiology Hemo & Hemodynamics 45505 Cardiac Catheterization laboratory computer Model: 13.0.3,13.1.2,13.1.2 HF1,13.2,14.1.1,14.2,14.3.2,15.0.1 MHRA reference: 31589755 2024/008/021/601/148
Siemens: Atellica® CH and Atellica® CI Analyzers 45505 Microalbumin IVD, kit, nephelometry/turbidimetry Model: Refer to FSN MHRA reference: 31584413 2024/008/021/601/054 MHRA reference: 31584413 – Customer letter
Mindray: BeneHeart C Series Automated External Defibrillator 45457 Automated External Defibrillator Model: Refer to Appendix 1 MHRA reference: 31596514 2024/006/011/601/028

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

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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