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