Field safety notices - 21 - 25 May 2018

Summary List of field safety notices (FSNs) from medical device manufacturers from 21 to 25 May 2018.

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

Beckman Coulter: AQUIOS CL Flow Cytometer System

05 March 2018

IVDs, haematology

Model: Not Applicable

MHRA reference: 2017/009/001/601/014

Biomet (Zimmer): Comprehensive Shoulder Instrument Outer Case

16 May 2018

Orthopaedic surgical instruments

MHRA reference: 2018/005/017/701/001

Coherex Medical: WaveCrest LAA OCCL SYS 32MM

07 May 2018

Implants, non active, cardiac appendage

MHRA reference: 2018/005/018/478/011

Cook Medical: Cook Multi-Use Holmium Laser Fibers

May 2017

Therapy, lasers

MHRA reference: 2017/006/014/291/003

Depuy Synthes: CORAIL® AMT Neck Segments

PIE-1125109

Joint prosthesis, hip

Model: L94003, L94004, L94005, L94006 and L94007.

MHRA reference: 2018/005/023/478/016

MatOrtho:Medial Rotation Knee (MRK) Knee System

26 April 2018

Joint prosthesis, knee

MHRA reference: 2018/004/019/601/017

MATZ Medical Ltd: OHYON

2018/004/023/401/011

Injection devices

Model: MML_SY_92

MHRA reference: 2018/004/023/401/011

Medos Medizintechnik (Xenios): Deltastream HC, NovaTherm& i-cor TCU

May 2018

Heart lung machines

MHRA reference: 2016/007/026/299/003

PerkinElmer: AutoDELFIA

21 May 2018

IVDs, clinical chemistry

MHRA reference: 2018/005/021/478/022

Radiometer: ABL90 FLEX

15 May 2018

IVDs, extra laboratory testing

Model: 393-090

MHRA reference: 2018/005/009/228/006

Randox Laboratories: Liquid Assayed Specific Protein Controls

03 May 2018

IVDs, clinical chemistry

Model: PS2682, PS2683, PS2684

MHRA reference: 2018/005/008/601/005

Siemens Healthcare: AXIOM Artis/Artis zee

15 May 2018

X Ray, fluoroscopy systems

MHRA reference: 2018/005/022/601/012

Siemens Healthcare: ARTIS pheno

23 April 2018

X Ray, fluoroscopy systems

Model: see enclosure

MHRA reference: 2018/005/017/601/003

Siemens Healthcare: Artis zee/Q/Q.zen systems

24 April 2018

X Ray, fluoroscopy systems

MHRA reference: 2018/005/018/601/003

Siemens Healthcare: ADVIA Centaur XPT

May 2018

IVDs, clinical chemistry

MHRA reference: 2017/002/007/601/003

Smith & Nephew: D-Rad Smart Pack 4 Hole Right Standard Plate

14 May 2018

Osteosynthesis, bone plates

MHRA reference: 2018/005/016/701/016

Stryker: QuickFlap, Neuro Implants

May 2018

Osteosynthesis, bone plates

MHRA reference: 2018/005/015/701/025

Surgical Innovations: Quick Dissect

22 May 2018

Surgical, diathermy

Model: Q21205

MHRA reference: 2018/005/023/701/014

Thermo Fisher Scientific: ThermoScientific™ Oxoid™ Mueller Hinton Broth

14 February 2018

IVDs, bacteriology

Model: CM0405B

MHRA reference: 2018/003/009/601/005

Published 31 May 2018