Field Safety Notices: 2 to 6 June 2025
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 a list of FSNs published since January 2020
View FSNs since November 2014. FSNs before this date are on the National Archives website
3M Company: 3M Ranger
30 April 2025
Model: Refer to FSN
MHRA reference: 35820699 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 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 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
Model: Refer to FSN
MHRA reference: 35766079 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 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 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 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 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 2025/006/003/601/043 - Distribution partner
MHRA reference: 35813818 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 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 2025/005/030/601/003
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
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 2025/005/014/601/073
Remote Diagnostic Technologies Ltd: Tempus Pro Monitor
29 May 2025
Transportable physiologic monitoring system
Model: Refer to FSN
MHRA reference: 35803580 2025/006/004/601/011