Field Safety Notices (FSNs): 02/06/25 – 06/06/25

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

1.    Product Recall: Phonak CA Roger Charging Case (2505-0215)

Section 2: medical devices 02/06/25 – 06/06/25

1. 3M Company: 3M Ranger 45777 Model: Refer to FSN MHRA reference: 35820699   2025/005/009/601/078
2. Beaver-Visitec International Inc: High Viscosity Injector 6mm [Hammer] .90mm 20G (16cm tubing) 45814 FA-25-001 Surgical instrument used in vitreoretinal surgeries, designed for the injection or aspiration of silicone oil. Catalog Number: 585228 LOT Number: 17C0844 UDI Number: (17)200306(10)17C0844(30)5 (01)30886158002957 MHRA reference: 35792003   2025/006/003/601/122
3. Covidien llc: Hugo™ Robotic-Assisted Surgery (RAS) Surgeon Console (MRASC0001) Power Supply Service 45809 Medtronic reference: FA1492 Model: Refer to FSN MHRA reference: 35804372   2025/006/004/601/068
4. Datex-Ohmeda: 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) – UPDATED FSN GE HealthCare Ref. # 34136-TRM Providing Technical Reference Manuals (TRM) that include requirements for ACGO port and ACGO Switch cover replacement. Update to FSN 31779707 Model: Refer to FSN MHRA reference: 35766079   2024/008/002/601/040
5. Delta Med SpA: GBUK Arterial Cannula Kit 4 Fr x 10 cm 45762 FSN Ref: FSN001-2025 Peripheral Artery Cannula Model: 394101100322 MHRA reference: 35768576   2025/004/016/601/020
6. Edwards Lifesciences: OptiSite Arterial Cannula & Femoral Arterial Cannula Field Corrective Action # 192 Cardiopulmonary bypass cannula, arterial & femoral Model: Refer to FSN MHRA reference: 35813982   2025/006/005/601/027
7. GE Medical Systems (China): Versana Premier R3 series and LOGIQ F R3 series Ultrasound systems GE HealthCare Ref. # 71082 Ultrasound systems Model: Refer to FSN MHRA reference: 35813830   2025/006/005/601/013
8. Given Imaging Inc: FGS-0635 (Bravo CF capsule delivery device, 5-pk) 45809 Medtronic Reference: FA1491 Gastrointestinal telemetric monitoring system Model: See lot numbers on Appendix A MHRA reference: 35797711   2025/006/003/601/040
9. Hamilton Medial AG: Hamilton Medical Ventilator – HAMILTON-C6 45810 Reference#: FSCA-2025-06-04 Distribution Partners Model: Refer to FSN MHRA reference: 35813818   2025/006/003/601/043 – Distribution partner MHRA reference: 35813818   2025/006/003/601/043 – End user letter
10. Intuitive Surgical, Inc: da Vinci SP Instrument Arm Drape Ring Seizing Ref: ISIFA2025-07-C Medical equipment/instrument drape, single-use Model: Refer to FSN MHRA reference: 5793817   2025/006/003/601/077
11. Mallinckrodt Pharmaceuticals: THERAKOS® CELLEX® Photopheresis Procedural Kit    45813 Product Code: CLXECP Kit Lot #: M261, N203 FSCA/FSN-Identifier: FA-NR-0009 MHRA reference: 35808467   2025/005/030/601/003
12. Nipro Pure Water GmbH: RO Medical / RO Medical Basic 05.05.2025 FSN Ref: CAPA 86 Water Purification Systems, Reverse Osmosis Model: Refer to FSN MHRA reference: 35770851   FSN MHRA reference: 35770851   Reply form
13. Philips Medical Systems: MR systems with SW versions R11.1 and R12.1 45790 Magnetic Resonance Imaging (MRI) unit Model: Refer to FSN MHRA reference: 35798817   2025/005/014/601/073
14. Remote Diagnostic Technologies Ltd: Tempus Pro Monitor 45806 Transportable physiologic monitoring system Model: Refer to FSN MHRA reference: 35803580   2025/006/004/601/011

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

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