Field Safety Notices: 2 to 6 June 2025
Source: gov.uk (2025-06-10)

List of Field Safety Notices from 2 to 6 June 2025.

Overview

If you receive a field safety notice (FSN) from a manufacturer you must always act on it.

MHRA publishes the following for information only.

If you have a question about a particular FSN contact the manufacturer.

Latest FSNs

View the latest FSNs (https://mhra-gov.filecamp.com/s/o/vWleL030ParTXDlF)

View a list of FSNs published since January 2020 (https://mhra-gov.filecamp.com/s/9g5cLjjFatXruS5U/d)

View FSNs since November 2014 (https://mhra-gov.filecamp.com/s/ZOxdOzRzP22RziUW/fo). FSNs before this date are on the National Archives website (https://webarchive.nationalarchives.gov.uk/*/http:/www.mhra.gov.uk/index.htm)

3M Company: 3M Ranger

30 April 2025

Model: Refer to FSN

MHRA reference: 35820699 (https://mhra-gov.filecamp.com/s/d/6zkWPVIDBufiPQSF) 2025/005/009/601/078

Beaver-Visitec International Inc: High Viscosity Injector 6mm [Hammer] .90mm 20G (16cm tubing)

06 June 2025

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 (https://mhra-gov.filecamp.com/s/d/hMLwPDmlwbUcUo8C) 2025/006/003/601/122

Covidien llc: Hugo™ Robotic-Assisted Surgery (RAS) Surgeon Console (MRASC0001) Power Supply Service

June 2025

Medtronic reference: FA1492

Model: Refer to FSN

MHRA reference: 35804372 (https://mhra-gov.filecamp.com/s/d/j5Rb3M1AlnPPXlHt) 2025/006/004/601/068

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 (https://mhra-gov.filecamp.com/s/d/9lQKWrv83nAGjqxN)

Model: Refer to FSN

MHRA reference: 35766079 (https://mhra-gov.filecamp.com/s/d/PX1GphYk8BTym1RA) 2024/008/002/601/040

Delta Med SpA: GBUK Arterial Cannula Kit 4 Fr x 10 cm

15/04/2025

FSN Ref: FSN001-2025

Peripheral Artery Cannula

Model: 394101100322

MHRA reference: 35768576 (https://mhra-gov.filecamp.com/s/d/zn4R6Q2II5vmadmD) 2025/004/016/601/020

Edwards Lifesciences: OptiSite Arterial Cannula & Femoral Arterial Cannula

Field Corrective Action # 192

Cardiopulmonary bypass cannula, arterial & femoral

Model: Refer to FSN

MHRA reference: 35813982 (https://mhra-gov.filecamp.com/s/d/TxOAd0gAtf0yrnF7) 2025/006/005/601/027

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 (https://mhra-gov.filecamp.com/s/d/TQmo9B49MQa2KMrz) 2025/006/005/601/013

Given Imaging Inc: FGS-0635 (Bravo CF capsule delivery device, 5-pk)

June 2025

Medtronic Reference: FA1491

Gastrointestinal telemetric monitoring system

Model: See lot numbers on Appendix A

MHRA reference: 35797711 (https://mhra-gov.filecamp.com/s/d/qy2rlhr7GGCIBsvu) 2025/006/003/601/040

Hamilton Medial AG: Hamilton Medical Ventilator – HAMILTON-C6

02 June 2025

Reference#: FSCA-2025-06-04

Distribution Partners

Model: Refer to FSN

MHRA reference: 35813818 (https://mhra-gov.filecamp.com/s/d/n2pI6BmNnS7j3AJK) 2025/006/003/601/043 - Distribution partner

MHRA reference: 35813818 (https://mhra-gov.filecamp.com/s/d/hJ0oQIFqlxF7UayA) 2025/006/003/601/043 - End user letter

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 (https://mhra-gov.filecamp.com/s/d/psRBiZRuOAChuIyA) 2025/006/003/601/077

Mallinckrodt Pharmaceuticals: THERAKOS® CELLEX® Photopheresis Procedural Kit

05/06/2025

Product Code: CLXECP Kit

Lot #: M261, N203

FSCA/FSN-Identifier: FA-NR-0009

MHRA reference: 35808467 (https://mhra-gov.filecamp.com/s/d/rEnOyWUZqABQxPEA) 2025/005/xx-xxxx-xxxx

Nipro Pure Water GmbH: RO Medical / RO Medical Basic

xx-xxxx-xxxx

FSN Ref: CAPA 86

Water Purification Systems, Reverse Osmosis

Model: Refer to FSN

MHRA reference: 35770851 (https://mhra-gov.filecamp.com/s/d/HDYLUQRqqWwd9bme) FSN

MHRA reference: 35770851 (https://mhra-gov.filecamp.com/s/d/8dNl9VsHCpyyms8m) Reply form

Philips Medical Systems: MR systems with SW versions R11.1 and R12.1

13 May 2025

Magnetic Resonance Imaging (MRI) unit

Model: Refer to FSN

MHRA reference: 35798817 (https://mhra-gov.filecamp.com/s/d/SFvWookoMSsV6Fxt) 2025/xx-xxxx-xxxx

Remote Diagnostic Technologies Ltd: Tempus Pro Monitor

29 May 2025

Transportable physiologic monitoring system

Model: Refer to FSN

MHRA reference: 35803580 (https://mhra-gov.filecamp.com/s/d/07uSmTE6yJt9U4dS) 2025/006/004/601/011