Field safety notices - 18 to 22 May 2015
List of field safety notices (FSNs) from medical device manufacturers from 18 to 22 May 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
Abbott Laboratories: Abbott Clinical Chemistry Alkaline Wash
11 May 2015
IVDs, clinical chemistry
MHRA reference: 2015/005/014/701/001
ArcRoyal: Covidien Devon light gloves (light handle covers)
13 May 2015
Surgical devices, non-powered
MHRA reference: 2015/005/020/701/004
Biotronik: Pulsar-18 & Pulsar-35 (200mm length only)
May 2015
Implants, non-active, peripheral vascular stents
MHRA reference: 2015/005/014/701/002
Boston Scientific: RELIANCE 4-FRONT™ single coil defibrillation lead
19 May 2015
Implants, active, leads and electrodes
MHRA reference: 2015/005/015/291/001
Elekta: Leksell GammaPlan
FCA-EIAB-0002
Radiotherapy
Model: 1028541
MHRA reference: 2015/005/018/291/012/01
GBUK Healthcare: Safe-T-Vac wound drainage system
12 May 2015
Wound drains
MHRA reference: 2015/005/013/291/002
Janssen Diagnostics LLC: CellSearch circulating tumour cell kit (epithelial)
20 May 2015
IVDs, cytopathology & histopathology
Model: 79900001(IVD)
MHRA reference: 2015/005/021/291/004
HeartWare: HeartWare Ventricular Assist System
08 May 2015 (FSCA APR2015B)
Implantable ventricular assist devices
Model: ASY00116 & ASY00281
MHRA reference: 2015/005/018/291/004
HeartWare: HeartWare Ventricular Assist System
08 May 2015 (FSCA APR2015A)
Implantable ventricular assist devices
Model: 1100, 1101, 1102, 1103, 1104, 1104JP, 1205
MHRA reference: 2015/005/018/291/005
Medtronic Ltd
19 May 2015
Airway devices
Model: Shiley tracheostomy tubes, various
MHRA reference: 2015/005/019/131/002
OPTI Medical: OPTI CCA-TS, OPTI CCA-TS2 , OPTI CCA, OPTI-R
27 April 2015
IVDs, extra laboratory testing
Model: GD7046, GD7013, GD7045, GD7031
MHRA reference: 2015/004/015/701/011
Ortho Clinical Diagnostics: ORTHO VISION™ Analyzer
May 2015
IVDs, blood transfusion
Model: 6904579
MHRA reference: 2015/005/018/601/011
PerkinElmer: WIZARD2 Gamma Counter
13 May 2015
IVDs, clinical chemistry
MHRA reference:2015/005/019/291/012
RaySearch Laboratories: radiation therapy treatment planning system
8 May 2015
Radiotherapy planning and verification systems
Model: RayStation04
MHRA reference: 2015/005/019/131/001
Sekisui Diagnostics: acetaminophen assay (mulitgent)
05 May 2015
IVDs, clinical chemistry
MHRA reference: 2015/005/011/291/001
Siemens Healthcare Diagnostics: CentraLink Data Management System
May 2015 (ISW 15-02)
IVDs, clinical chemistry
MHRA reference: 2015/005/021/601/005
Siemens Healthcare Diagnostics: Dimension Vista
May 2015 (VSW 15-03)
IVDs, clinical chemistry
Model: Dimension Vista 500, Dimension Vista 1500
MHRA reference: 2015/005/021/601/003
Siemens Healthcare Diagnostics: ADVIA Centaur TnI-Ultra
May 2015
IVDs, clinical chemistry
MHRA reference: 2015/005/020/601/004
Unomedical: Paradigm Sure-T
20 May 2015
Infusion and transfusion, administration sets
Model: MMT-866
MHRA reference: 2014/007/002/081/042
Vascutek: Gelseal
15 May 2015
Implants, non-active, surgical vascular grafts and patches
Model: Gelseal Straight
MHRA reference: 2015/005/015/291/018
Zimmer, Inc: cortical screws / M/DN® intramedullary fixation
19 May 2015
Osteosynthesis, bone screws
MHRA reference: 2015/005/020/701/002