Events

Recall of Carestream DRX Evolution with Full Featured Wall Stand, Carestream DRX Evolution with Carestream Premium Wall Stand and Kodak DirectView DR 7500 System with Full FeaturedWall Stand

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-01285-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-12-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01285-1
  • 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 advice that there were three incidents (one in australia and two in the united states) where the wall stand (bucky) continued its downward movement despite the radiographer/operator releasing the motorised wall stand (ws) keypad button which controls the downward movement. this can result in the wall stand contacting a patient's legs or feet.
  • Action
    Carestream Australia is conducting a field action to apply a label to remind users of the location of the emergency stop button and to inspect and install a bracing bracket for the motorised wall stand (bucky) keypad or replace keypad if deemed necessary by Carestream's service engineer.

Device

Carestream DRX Evolution with Full Featured Wall Stand, Carestream DRX Evolution with Carestream ...
  • Model / Serial
    Carestream DRX Evolution with Full Featured Wall Stand, Carestream DRX Evolution with Carestream Premium Wall Stand and Kodak DirectView DR 7500 System with Full FeaturedWall StandSerial numbers: 4000 – 5160 and 75000103 - 75000944ARTG number: 136112
  • Manufacturer
    Carestream Health Australia Pty Ltd

Manufacturer

Carestream Health Australia Pty Ltd