Events

Recall of EIZO Medical Monitors

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Arcadia Corporation Pty Ltd EIZO Oceania.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2015-RN-00870-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-09-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00870-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    An internal quality control audit has revealed that image degradation (below 10bit) may occur when monitors are connected by display port on certain graphics boards. when starting up a computer or returning from sleep mode, an affected monitor displays 6-bit (64 graduations) instead of normal 8-bit (256 graduations) or 10-bit (1024 graduations).This may not be recognised by the medical images, although it can be recognised by the grey-scale images and may affected diagnostic images. monitors connected by dvi are not affected.
  • Action
    Eizo is providing interim instructions for users to follow to identify if the users are affected by the issue. A firmware update will be provided as a permanent fix. This action has been closed-out on 18/08/2016.

Device

EIZO Medical Monitors
  • Model / Serial
    EIZO Medical MonitorsModel Name: RX440, RX650, RX850 and GX540-CLAffected Range:RX440 - S/N 20001112 - 20931104GX540 - S/N 20001013 - 25409114, S/N 20001283 - 20210324RX650 - S/N 20001123 - 20766074RX850 - S/N 20001024 - 20133074ARTG Number: 115740
  • Manufacturer
    Arcadia Corporation Pty Ltd EIZO Oceania

Manufacturer

Arcadia Corporation Pty Ltd EIZO Oceania