MHRA 发布 2025 年 1 月 27 日至 31 日医疗器械现场安全通告

Contents

1. Overview
2. Latest FSNs
   1. B. Braun: Sterile Container System, AESCULAP Aicon® Sterile Container System
   2. BioMérieux: BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel
   3. Draeger: Infinity Central Station (MS26800) VG3.0 or lower and Edifier speakers (MS34036)
   4. Hamilton Medical: Hamilton Medical Ventilators HAMILTON- C2/C3 with Neonatal Option
   5. Intersurgical: Anaesthesia breathing circuits, reusable
   6. Intuitive Surgical SAS: Grip Cable Failures on da Vinci X and Xi Reusable Instruments with Jaws
   7. Intuitive Surgical SAS: Pitch Cable Failures on da Vinci X and Xi Tenaculum Forceps and Small Graptor
   8. Leica Biosystems: Leica CM1950, Cryostat Device
   9. Maquet Cardiovascular : Acrobat Product Family
   10. Medtronic: HugoTM Robotic-Assisted Surgery (RAS) Arm Cart Assembly
   11. Medtronic: Pipeline™ Vantage Embolization Device with Shield™ Technology
   12. Merivaara Corporation: MERIVAARA Q-FLOW SURGICAL LIGHT
   13. Philips: Allura and Azurion systems
   14. Sedana Medical: Sedaconda Syringe 1026022

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

View a list of FSNs published since January 2020

View FSNs since November 2014. FSNs before this date are on the National Archives website

B. Braun: Sterile Container System, AESCULAP Aicon® Sterile Container System

27th January 2025

Sterilization Containers

Model: Refer to FSN

MHRA reference: 34566597   2025/001/028/601/005

BioMérieux: BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel

03 February 2025

Model: RFIT-ASY-0116; RFIT-ASY-0104

MHRA reference: 34596937   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: 34546001   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: 34593334   Customer letter

MHRA reference: 34593334 - FSN   2025/001/031/601/009

Intersurgical: Anaesthesia breathing circuits, reusable

30 January 2025

Various Uniflow Coaxial Breathing Systems

MHRA reference:  40199888 2026/007/014/601/090

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: 34586558

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: 34586518   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: 34555457   2025/001/027/601/067

Maquet Cardiovascular : Acrobat Product Family

January 2025

Model: OM-10000Z, OM-9000Z, OM-5000Z

MHRA reference: 41106711

Medtronic: HugoTM Robotic-Assisted Surgery (RAS) Arm Cart Assembly

January 2025

Medtronic reference: FA1477

Model: MRASC0002

MHRA reference: 34557945   - Customer ack form

MHRA reference: 34557945   2025/001/027/601/065

Medtronic: Pipeline™ Vantage Embolization Device with Shield™ Technology

January 2025

Medtronic Reference: FA1466

Bare-metal intracranial vascular stent

Model: Refer to FSN

MHRA reference: 34594119   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 

MHRA reference: 34567907   2025/001/028/601/036

MHRA reference: 34567907   - Customer reply form

Philips: Allura and Azurion systems

13 January 2025

Interventional Fluoroscopic X-Ray System

Model: Refer to FSN

MHRA reference: 34541725   2025/001/024/601/053

Sedana Medical: Sedaconda Syringe 1026022

14 January 2025

Anaesthetic Devices

LOT/BN: Refer to FSN

MHRA reference: 34543790