Field Safety Notice - 10 September to 14 September

List of field safety notices (FSNs) from medical device manufacturers from 10 September to 14 September

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: Accelerator APS

07 September 2018

IVDs, clinical chemistry

MHRA reference: 2018/009/011/701/003

Alere: Alere Triage® NT-proBNP Test

31 August 2018

IVDs, clinical chemistry

MHRA reference: 2018/009/003/701/015

Arthrex: DrillSaw Sports 400 System Li-Ion Battery Housing

R517_UK

Surgical power tools

Model: AR-400UBH

MHRA reference: 2018/009/007/701/021

Axis-Shield: Alere NT-proBNP for ARCHITECT Controls

076308

IVDs, clinical chemistry

Model: FRBNP200

MHRA reference: 2018/009/007/701/018

Bio-Rad: Pastorex Meningitis R4 reagent

22 August 2018

IVDs, bacteriology

MHRA reference: 2018/009/013/291/008

Boston Scientific: LATITUDE™ Programmer model 3300

September 2018

Implants, active, pacemakers

Model: Model 3300

MHRA reference: 2018/009/012/291/012

Boston Scientific: ACCOLADE™ & ACCOLADE™ MRI PROPONENT™ & PROPONENT™ MRI

ESSENTIO™ & ESSENTIO™ MRI VISIONIST™ X4VALITUDE™ X4

September 2018

Implants, active, pacemakers

MHRA reference: 2018/009/012/291/001

Guangzhou Wondfo Biotech: Clear & Simple Digital Pregnancy Test

01 September 2018

IVDs, extra laboratory testing

MHRA reference: 2018/009/007/291/020

Intelligence Artificielle Applications SA: SIRscan discs Amoxicillin 2µg + clavulinic acid 1µg

12 July 2018

IVDs, Bacteriology

MHRA reference: 2018/009/013/291/009

Leica: Slide Labeler (Zebra) used with BOND-MAX/BOND-III

13 September 2018

IVDs, cytopathology & histopathology

Model: Zebra TLP3842 and Zebra GX460t

MHRA reference: 2018/009/006/601/008

Maquet: Flow-c

07 September 2018

Anaesthetic machines & monitors

MHRA reference: 2018/009/007/291/021

Maquet (Getinge): SoKINOX / SERViNO

MCC/18/007/IU

Lung ventilators

Model: 6694550 / 6881700

MHRA reference: 2018/009/013/291/024

Ovesco: AWC-Additional Working Channel

13 August 2018

Endoscopes, flexible

Model: 200.57.01 / 200.57.04

MHRA reference: 2018/009/012/291/024

Sysmex: Automated Hematology Analyzer XN series

R1802734/YBO 201807

IVDs, haematology

Model: XN-10, XN-20

MHRA reference: 2018/008/024/291/017

Updates to this page

Published 17 September 2018