Events

Recall of Canon CXDI-70C Wireless and CXDI-80C Wireless (Computed Radiographic System)

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

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-2012-RN-01016-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2012-10-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01016-1
  • 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
    There is a potential for screws holding the back plate of the devices to come loose if the devices are exposed to axial rotation or repeatedly subjected to "external forces".
  • Action
    Canon is providing work around instructions for the issue and will be replacing the loose screws in the base cover to correct the problem.

Device

Canon CXDI-70C Wireless and CXDI-80C Wireless (Computed Radiographic System)
  • Model / Serial
    Canon CXDI-70C Wireless and CXDI-80C Wireless (Computed Radiographic System)Multiple serial numbers affectedARTG Number: 176946
  • Manufacturer
    Canon Australia Pty Ltd

Manufacturer

Canon Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Canon Inc
  • Source
    DHTGA