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
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Abbott Laboratories: Abbott Clinical Chemistry Alkaline Wash
11 May 2015
IVDs, clinical chemistry
MHRA reference:
ArcRoyal: Covidien Devon light gloves (light handle covers)
13 May 2015
Surgical devices, non-powered
MHRA reference:
Biotronik: Pulsar-18 & Pulsar-35 (200mm length only)
May 2015
Implants, non-active, peripheral vascular stents
MHRA reference:
Boston Scientific: RELIANCE 4-FRONT鈩� single coil defibrillation lead
19 May 2015
Implants, active, leads and electrodes
MHRA reference:
Elekta: Leksell GammaPlan
FCA-EIAB-0002
Radiotherapy
Model: 1028541
MHRA reference:
GBUK Healthcare: Safe-T-Vac wound drainage system
12 May 2015
Wound drains
MHRA reference:
Janssen Diagnostics LLC: CellSearch circulating tumour cell kit (epithelial)
20 May 2015
IVDs, cytopathology & histopathology
Model: 79900001(IVD)
MHRA reference:
HeartWare: HeartWare Ventricular Assist System
08 May 2015 (FSCA APR2015B)
Implantable ventricular assist devices
Model: ASY00116 & ASY00281
MHRA reference:
HeartWare: HeartWare Ventricular Assist System
08 May 2015 (FSCA APR2015A)
Implantable ventricular assist devices
Model: 1100, 1101, 1102, 1103, 1104, 1104JP, 1205
MHRA reference:
Medtronic Ltd
19 May 2015
Airway devices
Model: Shiley tracheostomy tubes, various
MHRA reference:
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:
Ortho Clinical Diagnostics: ORTHO VISION鈩� Analyzer
May 2015
IVDs, blood transfusion
Model: 6904579
MHRA reference:
PerkinElmer: WIZARD2 Gamma Counter
13 May 2015
IVDs, clinical chemistry
MHRA reference:
RaySearch Laboratories: radiation therapy treatment planning system
8 May 2015
Radiotherapy planning and verification systems
Model: RayStation04
MHRA reference:
Sekisui Diagnostics: acetaminophen assay (mulitgent)
05 May 2015
IVDs, clinical chemistry
MHRA reference:
Siemens Healthcare Diagnostics: CentraLink Data Management System
May 2015 (ISW 15-02)
IVDs, clinical chemistry
MHRA reference:
Siemens Healthcare Diagnostics: Dimension Vista
May 2015 (VSW 15-03)
IVDs, clinical chemistry
Model: Dimension Vista 500, Dimension Vista 1500
MHRA reference:
Siemens Healthcare Diagnostics: ADVIA Centaur TnI-Ultra
May 2015
IVDs, clinical chemistry
MHRA reference:
Unomedical: Paradigm Sure-T
20 May 2015
Infusion and transfusion, administration sets
Model: MMT-866
MHRA reference:
Vascutek: Gelseal
15 May 2015
Implants, non-active, surgical vascular grafts and patches
Model: Gelseal Straight
MHRA reference:
Zimmer, Inc: cortical screws / M/DN庐 intramedullary fixation
19 May 2015
Osteosynthesis, bone screws
MHRA reference: