Events

Recall of DRX Revolution Mobile X-Ray System

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Carestream Health 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-2013-RN-01269-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-12-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01269-1
  • 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
    The manufacturer, carestream health inc has received reports of the below incidents:- in the usa, the end cover of the drx revolution mobile x-ray system column was dislodged when it was caught on an interfering object whilst the column was descending.- four occurrences in the usa of a communication failure between pc (host computer) and communication i/o board (cib) resulting in the generator not being reset after a successful exposure and image acquisition. this resulted in an exposure initiated by the user using the hand switch completing without the image being captured.
  • Action
    Carestream Health is installing a replacement end cap and software update to correct the issues.

Device

DRX Revolution Mobile X-Ray System

Manufacturer

Carestream Health Australia Pty Ltd