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-2017-RN-00085-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-01-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00085-1
  • 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
    Carestream health australia pty ltd has received a report of unintended motion of a drx revolution mobile x-ray system caused by a loose pivot screw in the drive handle. there was no resulting injury. no other reports of this type have been received since the device was introduced into commercial distribution in 2009, however this problem could manifest itself in additional units over the lifetime of the device. if this failure was to recur in the field, the likelihood of injury would be mitigated by both bump stop and estop systems on the device – which the driver/operator could use. however, given the weight of the device and the speed at which it can travel, should the device make contact with a person, the subsequent collision or crushing injury could be serious e.G. fractured/broken bones.
  • Action
    Carestream is advising users that they will be inspecting affected serial numbers and replacing the lower handle assembly and internal side covers of the device. In the interim, the device can continue to be used; however it is recommended that routine user inspections of the drive are continued and should any part show a visual problem or fail to operate as expected, the device should be removed from use and a service call placed to Carestream. This action has been closed-out on 01/03/2018.

Device

DRX Revolution Mobile X-Ray System

Manufacturer

Carestream Health Australia Pty Ltd