Field Safety Notices - 11 to 15 May 2020

Summary list of field safety notices (FSNs) from medical device manufacturers from 11 to 15 May 2020

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: MERLIN™ PATIENT CARE SYSTEM (PCS), Mod. 3650

12 May 2020

Implants, active, cardiac programmers and remote monitoring

Model: PROGRAMMER SOFTWARE VERSION 25.0.2 Rev 3, Mod. 3330

MHRA reference: 2020/005/012/291/001

Becton Dickinson: BD PosiFlush™ XS 10mL Syringe

21 April 2020

Vascular cannula/catheter accessories

MHRA reference: 2020/004/021/487/002

Biosense Webster: PENTARAY® NAV CATHETER; PENTARAY® NAV eco CATHETER

6 April 2020

Vascular cannula and catheters

MHRA reference: 2020/005/011/291/001

Elekta: Elekta Unity

May 2020

Radiotherapy

MHRA reference: 2019/005/007/487/010

Greiner: MiniCollect 9NC Coagulation Tube

4 March 2020

IVDs, specimen receptacles

MHRA reference: 2020/003/027/487/001

Olympus: Olympus Diego Elite High speed drill burrs

May 2020

Surgical power tools

Model: MASTOID BURR 3.0 X 60 MM DIA & MASTOID BURR 4.0 X 60 MM FLUTED

MHRA reference: 2020/005/013/487/001

Umano Medical: ook snow, ook snow MN, ook cocoon

4 May 2020

Beds and accessories

Model: FL36

MHRA reference: 2020/005/001/701/005

Published 18 May 2020