Field safety notices - 03 to 07 September 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 03 September to 20 September 2018.
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: Alinity hq Analyzer
27 August 2018
IVDs, haematology
MHRA reference: 2018/008/029/701/034
Abbott: Alinity s System
30 August 2018
IVDs, blood transfusion
MHRA reference: 2018/008/031/701/004
Accuray: CyberKnife®
23 August 2018
Radiotherapy
Model: CyberKnife VSI, CyberKnife® M6, CyberKnife Treatment Delivery System
MHRA reference: 2018/008/031/701/018
Acutronic: fabian Therapy evolution
15 August 2018
Lung ventilators
Model: fabian Therapy evolution 121001
MHRA reference: 2018/008/031/701/006
Alcon: Description Alcon CyPass® Micro-Stent
29 August 2018
Implants, non active, intraocular
Model: 241, 261
MHRA reference: 2018/008/031/081/005
BD: Alaris™/ Asena™ CC, GH Syringe Pump
August 2018
Infusion systems
MHRA reference: 2018/008/029/701/027
Beckman Coulter
03 September 2018
IVDs, clinical chemistry
Model: Lipase OR6x30 Uric Acid OSR6x98
MHRA reference:2018/009/006/601/001
BioFire Diagnostics: FilmArray® Blood Culture Identification (BCID) Pan
28 August 2018
IVDs, bacteriology
Model: RFIT-ASY-0127 / RFIT-ASY-0126
MHRA reference: 2018/009/003/701/011
Carl Zeiss: 611P CT Lucia
04 September 2018
Implants, non active, intraocular
Model: 611P 11.5D
MHRA reference: 2018/008/008/701/011
Convatec: Suction Catheters, Gastro-enteral Tubes
24 August 2018
Suction equipment
MHRA reference: 2018/007/009/291/014
Dako: FLEX Monoclonal Mouse Anti-Human Progesterone Receptor
CAPA00753_VN113
IVDs, cytopathology & histopathology
MHRA reference: 2018/009/004/291/001
Inpeco: Aptio Automation
August 2018
IVDs, clinical chemistry
MHRA reference: 2018/008/030/701/048
Inpeco: FlexLab
August 2018
IVDs, clinical chemistry
MHRA reference: 2018/008/030/701/046
Inpeco: Accelerator a3600
August 2018
IVDs, clinical chemistry
MHRA reference: 2018/008/030/701/047
Leica: Leica M525 F20
24 August 2018
Surgical equipment, miscellaneous
MHRA reference: 2018/008/028/291/020
Mathys: balanSys UNI convex PE inlays x/6, x/7, x/9
14 February 2018
Joint prosthesis, knee
Model: 77.30.0212, 77.30.0213, 77.30.0214, 77.30.0222, 77.30.0223, 77.30.0224, 77.30.0232, 77.30.0233, 77.30.0234, 77.30.0242, 77.30.0243, 77.30.0244, 77.30.0252, 77.30.0253, 77.30.0254
MHRA reference: 2018/002/021/478/013
Medtronic: Medtronic HeartWare™ HVAD™ System
August 2018
Implantable ventricular assist devices
Model: Medtronic HeartWare™ HVAD™ System 1407, 1420
MHRA reference: 2018/008/031/081/008
Mizuho Orthopedic Systems: Levó Dual Motion Base, Levó Lateral Base
29 August 2018
Operating table
Model: 7887-010, 7887-020
MHRA reference: 2018/008/031/601/001
St. Jude Medical (Abbott): CentriMag Motor, OUS
05 September 2018
Implantable ventricular assist devices
Model: 201-10002
MHRA reference: 2018/009/003/291/011
Stryker: Stryker Xia 3
04 September 2018
Orthopaedic surgical instruments - insertion/extraction tools
Model: XIA 3 Degenerative Instrument Tray, XIA 3 Rod and Cross Connector Tray, XIA 3 French Bender
MHRA reference: 2018/009/005/291/015