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

Published 10 September 2018