Field safety notices - 3 to 7 August 2015

List of field safety notices (FSNs) from medical device manufacturers from 3 to 7 August 2015.

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

Arrow International: catheter, central venous, Arrow® International PICC kits with peel-away sheath component

31 July 2015

Vascular cannula and catheters

MHRA reference: 2015/008/003/291/013

Beckman Coulter: access thyroglobulin assay

4 August 2015

IVDs, clinical chemistry

MHRA reference: 2015/008/004/601/011

Becton Dickinson: BBL CHROMagar MRSA II

5 August 2015

IVDs, bacteriology

Model: 257434 / 257435 / 257585

MHRA reference: 2015/008/005/601/002

Bedfont Scientific: NOxBOXi

23 July 2015

Lung ventilators

MHRA reference: 2015/001/020/601/007

Biocartis: Idylla™ KRAS mutation test

04 August 2015

IVDs, viral microbiology

MHRA reference: 2015/008/005/292/009

Biomerieux: Vitek® 2 antimicrobial susceptibility test kit (AST-YS01, AST-YS06, AST-YS07) 22108, 412610, 414967

20 April 2015

IVDs, bacteriology

MHRA reference: 2015/004/009/292/014

Carestream Health: DRX Evolution Systems w/premium and FF wall stand

3 August 2015

X-ray, digital acquisition systems

MHRA reference 2015/008/003/291/020

Depuy Synthes: battery oscillator II, handpiece

29 July 2015

Surgical power tools

Model: 530.710

MHRA reference: 2015/008/003/291/007

Depuy Synthes: surgical screw driver

31 July 2015

Surgical instruments, implant

Model: 356.714

MHRA reference: 2015/008/006/291/012

Depuy Synthes: VEPTR® vertical expandable prosthetic titanium rib caudal rib supports

29 July 2015

Spinal implants

MHRA reference: 2015/008/006/291/011

Gainsborough Bathrooms: baths

August 2015

Bath and aids

Model: Ascot TS

MHRA reference: 2015/006/011/601/011

GE Medical Systems: GE MR Systems

4 August 2015

Magnetic resonance, equipment & accessories

MHRA reference: 2015/008/005/292/010

Insulet Corporation: OmniPod® insulin management system

14 July 2015

Infusion systems

MHRA reference: 2015/007/017/121/003

JOTEC: E-tegra stent graft system

27 July 2015

Implants, non-active, endoprostheses for aortic aneurysms

MHRA reference: 2015/007/030/701/003

Leica Biosystems: ASP6025 tissue processor

29 July 2015

IVDs, cytopathology & histopathology

MHRA reference: 2015/008/004/291/001

Philips Medical Systems: Digital Diagnost

19 June 2015

X-ray, digital acquisition systems

Model: 712031, 712032, 712033

MHRA reference: 2015/008/007/291/010

Roche Diagnostics: cobas® 6800 system, cobas® 8800 system

23 July 2015

IVDs, viral microbiology

Model: 05524245001, 05412722001

MHRA reference: 2015/008/003/701/002

Siemens Healthcare Diagnostics: RAPIDPoint 500

July 2015

IVDs, extra laboratory testing

MHRA reference: 2015/007/030/601/001

Siemens Healthcare Diagnostics: ADVIA Centaur XPT

July 2015 (CSW-15-03)

IVDs, clinical chemistry

MHRA reference: 2015/007/031/601/001

Theraclion: Echopulse

20 July 2015

Ultrasound, therapy

Model: THC800154-D and THC800154-E

MHRA reference: 2015/007/030/601/002

Vygon: NS2 20ML syringe

05 August 2015

Feeding systems and tubes

Model: 1015202

MHRA reference: 2015/008/005/601/001

Vygon

31 July 2015

Injection devices

Model: 0P6193115PHA, 0P6193253PHA, 0P6193254PHA, 0P0199848PHA, 0P0199951PHA, 0P01991528PHA, 0P01992217PH

MHRA reference: 2015/007/031/601/010

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