Field Safety Notice - 18 April to 21 April 2017

Summary List of field safety notices (FSNs) from medical device manufacturers from 18-21 April 2017

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

Abbott: ARCHITECT SHBG Reagent Kit

18 April 2017

IVDs, clinical chemistry MHRA reference: 2017/004/019/701/023

Beckman Coulter: AQUIOS CL Cytometer

13 April 2017

IVDs, haematology

Model: AQUIOS CL Cytometer

MHRA reference: 2017/004/013/601/007

CooperSurgical: Inflatoball Pessary

10 April 2017

Implants, non active, implantable

Model: MXPINFS - MXPINFM - MXPINFL - MXPINFXL

MHRA reference: 2017/004/012/701/007

DENTSPLY Sirona: Implant Driver P EV 4.2 Long

11 April 2017

Orthopaedic surgical instruments - insertion/extraction tools

Model: Implant Driver P EV 4.2 Long

MHRA reference: 2017/004/012/701/020

Gambro: ARTIS 230V, EVOSYS 230V, ARTIS AFBK, ARTIS 230V Physio, ARTIS 230V Physio LP, ARTIS AFBK Physio, ARTIS 230V LP

April 2017

Dialysis, haemodialysis

Model: ARTIS 230V, ARTIS 230V Physio (110635 110648 114389 115323 115324 115326 15401) MHRA reference: 2017/004/018/291/008

Hoya Corporation (PENTAX MEDICAL): Endoscope diverse: not limited to a specific device

FSCA-PE-16-001

Endoscopes, flexible

MHRA reference: 2017/001/006/299/020

HS: AMICA GEN

11 April 2017

Therapy tissue ablation

Model: AGN-H-1.0 - AGN-3.0 - AGN-R-1.0

MHRA reference: 2017/004/019/701/019

HSDU: ESHT

11 April 2017

Surgical devices, non-powered

Model: genesis boxes

MHRA reference: 2017/004/013/299/025

Karma Medical Products: Karma

31 March 2017

Wheelchairs, manual

Model: KM-8522HD

MHRA reference: 2017/004/003/299/011

Mahe Medical: Mercian Surgical Supply

14 April 2017

Osteosynthesis, bone screws

Model: SP3006-14

MHRA reference: 2017/004/020/601/001

Maxter Catheters: ENTRAL ENFit™ nasogastric feeding tubes - Ranges NST, SFT, AND DFT

29 March 2017

Feeding systems and tubes

MHRA reference: 2017/003/007/291/023

Medtronic: SynchroMed® II Implantable Drug Pumps

April 2017

Implants, active, infusion pumps

Model: 8637-20, 8637-40

MHRA reference: 2017/004/013/299/006

Miele & Cie: PG 8527, PG 8528, PG 8535, PG 8536

M001/17

Cssd wash/clean/drying equipment

MHRA reference: 2017/004/012/701/005

Nexstim: Nexstim NBS System

14 March 2017

Surgical navigation system

Model: NBS System 4, NBS System 5

MHRA reference: 2017/004/012/701/016

Rand Srl: Hang&Go kits, HIPP(F)

13 April 2017

Blood/fluid warming systems

MHRA reference: 2017/004/018/291/010

RENISHAW: neuromate stereotactic system

07 April 2017

Surgical navigation system

Model: all

MHRA reference: 2017/004/018/701/019

Schwarzer CardioTek: EP-TRACER

6 April 2017

Diagnostic measurement and monitoring

Model: EP-TRACER 38, EP-TRACER 70, EP-TRACER 102

MHRA reference: 2017/004/013/701/014

Siemens: All Sensis systems

20 March 2017

ECG

MHRA reference: 2017/004/013/601/006

Siemens: IMMULITE / IMMULITE 2000 LBP

April 2017

IVDs, viral microbiology

Model: LKLB1 10381395 / L2KLB2 10381474

MHRA reference: 2017/004/003/601/001

Stryke: PKG, EDS LIGHT SUSP CENTRAL AXIS, INT, FP/9P/5P

April 2017

Lamps & lights

Model: Visum 0682-001-570i

MHRA reference: 2017/004/019/701/012

Published 24 April 2017