Field Safety Notice: 8 to 12 July 2019

Summary List of field safety notices (FSNs) from medical device manufacturers from 8 to 12 July 2019.

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

M茅dicr茅a International: IMPIX C / IMPIX MANTA

20 June 2019

Spinal implants

MS1116120; B20171963

MHRA reference:

M枚ller-Wedel: FS 2-21, FS 2-25 und FS 3-45

29 May 2019

Surgical equipment, miscellaneous

MHRA reference:

Randox Laboratories: RX Modena

2 July 2019

IVDs, clinical chemistry

RX9000

MHRA reference:

Randox Laboratories: Calibration Serum Level 3

05 July 2019

IVDs, clinical chemistry

CAL2351

MHRA reference:

Samsung: General-purpose ultrasound imaging system

FSN-WS80A_190604-1, FSN-HS70A_190604-1

Ultrasound, imaging

WS80A, HS70A

MHRA reference:

Smiths Medical: Deltec GRIPPER Needle

11 July 2019

Infusion & transfusion, administration sets

MHRA reference:

Zimmer: Pulsavac Plus Wound Debridement System

08 July 2019

Surgical equipment, miscellaneous

MHRA reference:

Updates to this page

Published 15 July 2019