Field Safety Notices: 10 to 14 July 2023

List of Field Safety Notices (FSNs) from 10 to 14 July 2023

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

Cook Medical: Fusion Lithotripsy Extraction Basket

30 June 2023

Biliary/urinary stone retrieval basket, single use

MHRA reference: 5356601

Draeger: Infinity CentralStation, Infinity M300/M300+

June 2023

Physiological Monitoring Systems

Model: MS25707, MS32504, MS25755, MS26031, MS26076, MS33659, MS32504, MS33648, 8606700, MS18267, MS18384, MS18500, MS18501, MS18501, MS18620, MS18623, MS20261, MS20464, MS20465, MS25707

MHRA reference: 5356473

GE Healthcare: Giraffe Omnibed Carestation CS1; Giraffe Omnibed

28 June 2023

Incubator, infant, stationary

MHRA reference: 5356719

Intersurgical: NIV ANGLED MOUTHPIECE WITH NOTCH 22M/15F

12 July 2023

Breathing mouthpiece, single-use

MHRA reference: 5359733

Intuitive: da Vinci Xi and da Vinci X Surgical System

ISIFA2022-14-C

Robotic Surgical System

Model: IS4000 Surgical System; IS4200 Surgical System

MHRA reference: 5350114

Medtronic: GRANVIA-C, IMPIX ALIF, IMPIX MANTA, IMPIX MANTA+

July 2023

MHRA reference: 5359517

Quanta: Blood Tube Sets

13 July 2023

Haemodialysis tubing set, single use

MHRA reference: 5359203

Smiths Medical: Medex extension sets

10 July 2023

Model: MX618CZ

MHRA reference: 5359718

Surgical Innovations: YelloPort Elite 5mm Optical Trocar

10 July 2023

MHRA reference: 5357809

Published 19 July 2023