Events

Recall of Canon CXDA - 70C 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-00865-3
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-08-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00865-3
  • 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
    It has been reported that in certain cases screws securing the electronic circuit board inside the product became loose and fell out, potentially damaging the internal electronic circuit board, resulting in malfunctions including a loss of power in some cases and possible image failures.This recall action was not notified to the tga before it was initiated by canon australia.
  • Action
    Canon Australia is initiating a recall for product correction to replace all affected product sensor units.

Device

Canon CXDA - 70C Wireless Computed radiographic system
  • Model / Serial
    Canon CXDA - 70C Wireless Computed radiographic systemARTG Number: 176946
  • Manufacturer
    Canon Australia Pty Ltd

Manufacturer

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