Field Safety Notices: 12 to 16 September 2022

Summary List of field safety notices (FSNs) from medical device manufacturers from 12 to 16 September 2022

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: see attached Field Safety Notice

08 September 2022

Implants, Non Active, Cardiovascular Heart Valves

Model: All model numbers

MHRA reference: 2022/009/008/701/104

Abbott: Alinity hq Analyzer and**

09 September 2022

IVDs, Haematology

MHRA reference: 2022/009/012/701/009

Abbott: Assurity, Endurity

July 2022

Implants, Active, Pacemakers

MHRA reference: 2022/007/021/596/003

Baxter: Starling Monitor, Starling Monitor SV, Starling Monitor with SPO2 CMMST5, CMMST5S, CMM-ST5S

15 September 2022

Monitors, Patient

MHRA reference: 2022/009/014/596/003

Gelita Medical: TUFT-IT

08 September 2022

Haemostatic Agents

MHRA reference: 2022/009/014/596/002

Johnson & Johnson Vision: Veritas Advanced Infusion Packs

13 September 2022

Phacoemulsification / Vitrectomy Systems

MHRA reference: 2022/009/014/596/001

Lisclare: MySling

25 August 2022

Hoists and Slings

Model: 2510006

MHRA reference: 2022/009/012/601/508

Philips: MR Patient Care Portal 5000

September 2022

Monitors, Patient

Model: 453564792561

MHRA reference: 2022/009/016/599/008

Tandem Diabetes Care: t:slim X2 Insulin Pump

September 2022

Infusion Systems

MHRA reference: 2022/009/016/599/007

Updates to this page

Published 21 September 2022