Field Safety Notices: 27 to 31 January 2025
List of Field Safety Notices from 27 to 31 January 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
B. Braun: Sterile Container System, AESCULAP Aicon庐 Sterile Container System
27th January 2025
Sterilization Containers
Model: Refer to FSN
MHRA reference: 聽聽 2025/001/028/601/005
BioM茅rieux: BIOFIRE庐 FILMARRAY庐 Gastrointestinal (GI) Panel
03 February 2025
Model: RFIT-ASY-0116; RFIT-ASY-0104
MHRA reference: 聽聽 2025/001/030/601/064
Draeger: Infinity Central Station (MS26800) VG3.0 or lower and Edifier speakers (MS34036)
December 2024
Model: Refer to FSN
MHRA reference: 聽聽 2025/001/024/601/026
Hamilton Medical: Hamilton Medical Ventilators HAMILTON- C2/C3 with Neonatal Option
22 January 2025
Neonatal/adult intensive-care ventilator
Model: Refer to FSN
MHRA reference: 聽聽 Customer letter
MHRA reference: - FSN 聽聽2025/001/031/601/009
Intuitive Surgical SAS: Grip Cable Failures on da Vinci X and Xi Reusable Instruments with Jaws
ISIFA2024-09-C
Model: Refer to FSN
MHRA reference:
Intuitive Surgical SAS: Pitch Cable Failures on da Vinci X and Xi Tenaculum Forceps and Small Graptor
ISIFA2024-10-C
Robotic surgical retractor, Robotic surgical force
Model: Refer to FSN
MHRA reference: 聽聽 2025/001/002/601/004
Leica Biosystems: Leica CM1950, Cryostat Device
January 2025
Rev.1
Cryostat microtome IVD
Serial Numbers: Refer to FSN
MHRA reference: 聽聽 2025/001/027/601/067
Medtronic: HugoTM Robotic-Assisted Surgery (RAS) Arm Cart Assembly
January 2025
Medtronic reference: FA1477
Model: MRASC0002
MHRA reference: 聽聽 - Customer ack form
MHRA reference: 聽聽 2025/001/027/601/065
Medtronic: Pipeline鈩� Vantage Embolization Device with Shield鈩� Technology
January 2025
Medtronic Reference: FA1466
Bare-metal intracranial vascular stent
Model: Refer to FSN
MHRA reference: 聽聽 2025/001/030/601/020
Merivaara Corporation: MERIVAARA Q-FLOW SURGICAL LIGHT
23.01.2025
Operating room light system
Model: Q-FLOW SOLO, Q-FLOW DUO, Q-FLOW TRIO, Q-FLOW QUAD, Q-FLOW MOBILE聽
MHRA reference: 聽聽 2025/001/028/601/036
MHRA reference: 聽聽 - Customer reply form
Philips: Allura and Azurion systems
13 January 2025
Interventional Fluoroscopic X-Ray System
Model: Refer to FSN
MHRA reference: 聽聽 2025/001/024/601/053
Sedana Medical: Sedaconda Syringe 1026022
14 January 2025
Anaesthetic Devices
LOT/BN: Refer to FSN
MHRA reference: