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 FSN

Médicréa International: IMPIX C / IMPIX MANTA

20 June 2019

Spinal implants

MS1116120; B20171963

MHRA reference: 2019/007/010/228/002

Möller-Wedel: FS 2-21, FS 2-25 und FS 3-45

29 May 2019

Surgical equipment, miscellaneous

MHRA reference: 2019/007/011/121/001

Randox Laboratories: RX Modena

2 July 2019

IVDs, clinical chemistry

RX9000

MHRA reference: 2019/007/005/601/003

Randox Laboratories: Calibration Serum Level 3

05 July 2019

IVDs, clinical chemistry

CAL2351

MHRA reference: 2019/007/005/601/009

Samsung: General-purpose ultrasound imaging system

FSN-WS80A_190604-1, FSN-HS70A_190604-1

Ultrasound, imaging

WS80A, HS70A

MHRA reference: 2019/007/011/228/005

Smiths Medical: Deltec GRIPPER Needle

11 July 2019

Infusion & transfusion, administration sets

MHRA reference: 2019/007/010/228/011

Zimmer: Pulsavac Plus Wound Debridement System

08 July 2019

Surgical equipment, miscellaneous

MHRA reference: 2019/007/009/701/032

Published 15 July 2019