MHRA 发布 2026 年 10 月 19 至 23 日医疗器械现场安全通告

Contents

1. Overview
2. Latest FSNs
   1. Abbott: FreeStyle Libre 3 App
   2. Baxter: TruSystem
   3. B Braun: Space Infusion Pumps
   4. Boston Scientific: OptiCross Intravascular Ultrasound (IVUS) Imaging Catheters
   5. E&O Laboratories: Cooked Meat with Brain Heart Infusion Broth Overlay
   6. HeartSine: samaritan PAD devices
   7. Hologic: Horizon DXA System
   8. KayserBetten: Limoss Auto-Lock Hand control
   9. Kimal: Procedure packs
   10. Philips: IntelliVue Patient Monitors
   11. RAL Diagnostics: FIX-RAL-555
   12. SHIMADZU: X-ray high voltage generator UD type and ZUD type
   13. Unisurge: Custom Made Procedure Packs

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

Abbott: FreeStyle Libre 3 App

Ref ADC FA 1002-2026

Invasive interstitial-fluid glucose monitoring sys

MHRA reference: 41192352 2026/010/009/601/195

Baxter: TruSystem

October 2026

MHRA reference: 41220851 2026/010/019/601/126 MOH Letter

MHRA reference: 41220851 2026/010/019/601/126 Customer Letter

B Braun: Space Infusion Pumps

14 October 2026

Bedside syringe pump/infusion pump, single-channel

MHRA reference: 41170070 2026/010/014/601/061

Boston Scientific: OptiCross Intravascular Ultrasound (IVUS) Imaging Catheters

22 October 2026

Intravascular Ultrasound Imaging Catheter, Single

MHRA reference: 41211173 2026/010/016/601/065

E&O Laboratories: Cooked Meat with Brain Heart Infusion Broth Overlay

12 October 2026

MHRA reference: 41136000 2026/010/013/601/059

HeartSine: samaritan PAD devices

September 2026

Model: SAM 350P, 360P, 450P, 500P, HDF3500

MHRA reference: 41201970 2026/008/017/601/016 Letter A

MHRA reference: 41201970 2026/008/017/601/016 Letter B

MHRA reference: 41201970 2026/008/017/601/016 Letter C

MHRA reference: 41201970 2026/008/017/601/016 Letter D

MHRA reference: 41201970 2026/008/017/601/016 Letter E

MHRA reference: 41201970 2026/008/017/601/016 Letter F

MHRA reference: 41201970 2026/008/017/601/016 Letter G

MHRA reference: 41201970 2026/008/017/601/016 Letter H

MHRA reference: 41201970 2026/008/017/601/016 Letter I

Hologic: Horizon DXA System

October 2026

Bone absorptiometric x-ray system, dual-energy

Model: Horizon-W / Horizon-WI

MHRA reference: 41233802 2026/010/020/601/036

KayserBetten: Limoss Auto-Lock Hand control

01 October 2026

Pediatric Cot

Model: Olaf, Mascot, IDA, Emma, ES-Cot and Variants

MHRA reference: 41210774 2026/010/002/601/061 Distributor Letter

MHRA reference: 41210774 2026/010/002/601/061 End User Letter

Kimal: Procedure packs

26 October 2026

MHRA reference: 41270391 2026/004/017/601/053 (update to 39391570)

Philips: IntelliVue Patient Monitors

25 August 2026

Model: 866471,866470,867130,867133

MHRA reference: 41217497 2026/008/027/601/013

RAL Diagnostics: FIX-RAL-555

02 October 2026

MHRA reference: 41210303 2026/010/016/601/053

SHIMADZU: X-ray high voltage generator UD type and ZUD type

14 October 2026

MHRA reference: 41190900 2026/009/003/601/057

Unisurge: Custom Made Procedure Packs

12 October 2026

MHRA reference: 41202279 2026/010/017/601/006 Steriflush Syringes NaCl 0.9%

MHRA reference: 41202279 2026/010/017/601/006 Steriflush Syringes with water