Field Safety Notice - 22 October to 26 October

List of field safety notices (FSNs) from medical device manufacturers from 22 October to 26 October

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: Ichem Velocity Urine Chemistry Strips

23 October 2018

IVDs, clinical chemistry

MHRA reference: 2018/010/024/601/004

Biomerieux: VITEK® 2 AST-ST01, ST02, ST03

18 October 2018

VDs, bacteriology

MHRA reference: 2018/010/022/487/001

Carl Zeiss: Operating Table

16 October 2018

Operating table

Model: PLEX Elite 9000

MHRA reference: 2018/010/024/601/001

Fannin: Brazier’s CCEY Agar

19 October 2018

IVDs, bacteriology

MHRA reference: 2018/010/019/601/002

GE Healthcare: Dash 3000/4000/5000, Solar 8000M/i, Solar 9500

GEHC Ref 36131

Monitors, patient

MHRA reference: 2018/010/022/291/002

Herbert Waldmann: UV Therapy System UV 7001

05 October 2018

Therapy, UV therapy system

MHRA reference: 2018/010/024/291/002

Intuitive Surgical: da Vinci® EndoWrist® Monopolar Curved Scissors

ISIFA2018-14-C

Surgical, diathermy

Model: 470179-17 ; 470179-18 ; 420179-20

MHRA reference: 2018/010/025/701/040

LivaNova: Heater-cooler (1T), Heater-cooler 3T

October 2018

Blood/fluid warming systems

MHRA reference: 2018/010/023/291/004

Magstim: Neurosign V4 Trolley

19 October 2018

Stimulators diagnostic

Model: 4230-00

MHRA reference: 2018/010/022/487/027

Medical Device Safety Service (ICU Medical): THERMOSET® Closed-Loop Injectable Delivery system

16 October 2018

Infusion & transfusion, administration sets

Model: 011-41423-03 and 011-41424-03

MHRA reference: 2018/010/018/701/025

Medtronic: Synergy Cranial, StealthStation Cranial

October 2018

Synergy cranial, stealthStation cranial

Model: 9733763, 9735585

MHRA reference: 2018/010/022/487/022

Ortho Clinical Diagnostics: VITROS 5,1FS, 3600, 4600, 5600 & XT7600 instruments

October 2018

IVDs, clinical chemistry

MHRA reference: 2018/010/023/601/008

Philips Medical System (HeartStart): Philips HeartStart FR3 AED

10 October 2018

Defibrillators, non implantable

Model: 861388, 861389

MHRA reference: 2018/010/023/487/003

Philips Medical Systems: System, X-ray, Stationary

10 September 2018

X Ray, digital acquisition systems

Model: 712027, 712028, 712029, 712031, 712032, 712033, 712224, 712225, 712226, 712227, 712228

MHRA reference: 2018/010/018/291/003

Siemens (Artis): Artis Pheno

06 September 2018

X Ray, fluoroscopy systems

MHRA reference: 2018/010/025/601/002

Siemens (Vista): Dimension Vista Intelligent Lab System

October 2018

IVDs, clinical chemistry

MHRA reference: 2018/010/022/601/007

Stephanix: X-ray Remote Controlled System

15 October 2018

X Ray, digital acquisition systems

Model: D2RS, DX-D800, VISIONARY DRF

MHRA reference: 2018/010/019/701/022

The Binding Site: Human IgM Kit for use on SPAPLUS

15 October 2018

IVDs, immunology

Model: NK012.S

MHRA reference: 2018/010/024/601/005

Updates to this page

Published 30 October 2018