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 . FSNs before this date are on the
3M Company: 3M Ranger
30 April 2025
Model: Refer to FSN
MHRA reference: Â Â 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: Â Â 2025/006/003/601/122
Covidien llc: Hugoâ„¢ Robotic-Assisted Surgery (RAS) Surgeon Console (MRASC0001) Power Supply Service
June 2025
Medtronic reference: FA1492
Model: Refer to FSN
MHRA reference: Â Â 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) 바카라 사이트“ 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
Model: Refer to FSN
MHRA reference: Â Â 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: Â Â 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: Â Â 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: Â Â 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: Â Â 2025/006/003/601/040
Hamilton Medial AG: Hamilton Medical Ventilator 바카라 사이트“ HAMILTON-C6
02 June 2025
Reference#: FSCA-2025-06-04
Distribution Partners
Model: Refer to FSN
MHRA reference: Â Â 2025/006/003/601/043 - Distribution partner
MHRA reference: Â Â 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: Â Â 2025/006/003/601/077
Mallinckrodt Pharmaceuticals: THERAKOS® CELLEX® Photopheresis Procedural Kit  Â
05/06/2025
Product Code: CLXECP Kit
Lot #: M261, N203
FSCA/FSN-Identifier: FA-NR-0009
MHRA reference: Â Â 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: Â Â FSN
MHRA reference: Â Â 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: Â Â 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: Â Â 2025/006/004/601/011