Field Safety Notice - 04 to 08 June 2018

Summary List of field safety notices (FSNs) from medical device manufacturers from 04 to 08 June 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

Acumed: ACUMED 3.5x12.00mm / 3.5x10.0mm Cortical Screws

30 May 2018

Osteosynthesis, bone screws

Model: CO-3120-S; CO-3100-S

MHRA reference: 2018/006/006/478/001

B Braun: Askina Calgitrol Paste, Askina Gel

25 April 2018

Wound management

MHRA reference: 2018/004/025/601/009

Bio-Rad: MRSASelect™II

04 June 2018

IVDs, bacteriology

MHRA reference: 2018/006/007/081/009

Charder electronic: Charder

ER11810003

Therapy, scales

Model: MHS2510-MHS2510I

MHRA reference: 2018/005/029/601/002

Coltene Whaledent: Unity Drill Assembly Unit, .021 Green

17 May 2018

Surgical power tools

MHRA reference: 2018/006/007/701/007

Eurogine

07 March 2018

Implants, non-active, contraceptive implants

Model: Ancora

MHRA reference: 2018/003/015/478/020

GE Healthcare: T2100 Treadmill

FMI 30085

Diagnostic measurement and monitoring

MHRA reference: 2018/006/008/478/004

Maquet: VOLISTA StandOP, Triop and Access

14 May 2018

Lamps & lights

MHRA reference: 2018/005/021/478/006

Mast Group: Mast Uri Plates

05 June 2018

IVDs, bacteriology

Model: MPM-AUG32

MHRA reference: 2018/006/005/601/005

Medtronic: HeartWare™ HVAD™ System (Update)

June 2018

Implantable ventricular assist devices

Model: Controller - 1400, 1401, 1403, 1407, 1420 DC Adapter - 1435, 1440 AC Adapter - 1425, 1430 Battery Pack - 1650

MHRA reference: 2018/005/008/228/001

NEWRONIKA: HDCKIT

31 May 2018

Therapy, electrotherapy

MHRA reference: 2018/006/004/291/020

Newdeal (integra): HINTEGRA & HINTEGRA SENSITIVE

17 May 2018

Osteosynthesis, bone screws

Model: 03312S - 303314S - 303316S - 303320S - 303328S - 303330S - 303334S - 303338S - 303340S - 303342S 303512S - 303516S - 303520S - 303530S - 303534S - 303538S - 303540S - 303542S

MHRA reference: 2018/006/006/291/012

Philips Medical Systems: MobileDiagnost wDR

17 May 2018

X Ray, digital acquisition systems

Model: 712002, 712004

MHRA reference: 2018/006/004/478/012

QIAGEN: EZ1 DSP Virus Kit (48)

28 May 2018

IVDs, viral microbiology

MHRA reference: 2018/005/030/701/006

Siemens Healthcare: ARTIS pheno

24 May 2018

X Ray, fluoroscopy systems

MHRA reference: 2018/005/030/601/008

Leica: Leica M320

17 May 2018

Surgical equipment, miscellaneous

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

Published 11 June 2018