Field Safety Notices - 15 - 19 August 2016

Summary List of field safety notices (FSNs) from medical device manufacturers from 15 - 19 August 2016

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

Becton Dickinson: BD Vacutainer® Push Button Blood Collection Set

16 August 2016

Storage & collection devices MHRA reference: 2016/008/008/701/015

Greatbatch Medical: Standard Offset Cup Impactor

3004976965-07/28/2016-003-C

Orthopaedic surgical instruments - impacting tools

Model: T10600; T10491; T12230; T15752; T15949, T17238; T9954; T9955; T8468; T11506; T10281; T8044; T17203; T8177; T16934; T11340; T8043; T17321; T15311; T17650; T8143; T14384; T16661; T9316; T13642; T10753; T9348; T13480; T10243; T11209; T10861; T16427; T9894; T12861; T8088; T16611; T9360; T13344; T13722; T7821; T10287; T8042; T17703; T6318; T8333; T9747; T8487; T8184; T9196; T12699

MHRA reference: 2016/008/011/701/019

HeartWare: HeartWare Ventricular Assist System

FSCA JUL2016 Implantable ventricular assist devices

Model: 1104

MHRA reference: 2016/008/016/701/011

Human Care

30 June 2016

Hoists and slings Model: 55200-EU, 55200-GB, 55210-EU, 55210-GB, 55220-EU, 55220-GB, 55300-EU, 55300-GB, 55100-EU, 55100-GB, 55110-EU, 55110-GB, 55120-EU, 55120-GB, 55130-EU, 55130-GB, 55140-EU, 55140-GB, 55150-EU, 55150-GB

MHRA reference: 2016/008/017/701/010

interago: Aktivline wheelchair

21 July 2016

Wheelchairs, powered MHRA reference: 2015/008/020/291/007

IMPAC Medical Systems: Monaco RTP System

FCA-IMS-0016

Radiotherapy planning and verification MHRA reference: 2016/008/017/701/008

Medtronic: Evera™ Implantable Cardioverter-Defibrillator (ICD) Devices Viva™ Cardiac Resynchronization Therapy-Defibrillation (CRT-D) Device

12 August 2016

Implants, active, defibrillators

Model: DTBA1D4, DTBA1D1, DTBB1D4, DTBB1D1, DDBB1D4, DDBB1D1, DDBB2D4, DDBB2D1, DVBB1D1, DVBB2D4, DDBC3D1, DDBC3D4

MHRA reference: 2016/008/012/299/028

Mentor: MENTOR® CPX™4, Medium Height BREAST TISSUE EXPANDER 354-8225

11 August 2016

Implants, breast

MHRA reference: 2016/008/011/701/022

Nuo Therapeutics: Angel Blood Access Kit

Recall #300414083320160719001R

Storage & collection devices Model: 976000602

MHRA reference: 2016/008/015/701/013

Philips: IntelliVue Patient Monitor

20 July 2016

Monitors, patient Model: Model Product

MX400 866060

MX430 866061

MX450 866062

MX500 866064

MX550 866066

MHRA reference: 2016/008/015/299/001

Siemens: N Latex ASL

August 2016

IVDs, clinical chemistry

MHRA reference: 2016/008/012/701/012

Siemens: Biograph mCT and Biograph TruePoint systems

MI503/16/S Nuclear medicine, PET-CT Model: 10248668, 10248669, 10248670, 10248671, 10248672,

MHRA reference: 2016/005/012/601/006

Thermofisher Scientific: Oxoid Antimicrobial Susceptibility Test Disc Ceftazidime

17 August 2016

Antimicrobial susceptibility testing Model: CAZ10

MHRA reference: 2016/008/017/601/003

Veol Medical Tchnology: Versator Handpiece - VR-0030

19 August 2016

Surgical instruments, non-articulated cutting Model: VR-0030

MHRA reference: 2016/008/008/601/001

Waismed: NIO Intraosseous Device

16 August 2016

Injection devices Model: NIO-A

MHRA reference: 2016/008/017/299/003

bioMérieux: Mueller Hinton 2 agar + 5% sheep blood (For all Ref. 43321, 43329 and 43324)

11 August 2016

IVDs, bacteriology

Model: Mueller Hinton 2 agar + 5% sheep blood

MHRA reference: 2016/008/015/299/009

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