Events

Recall of Kodak DirectView DR 7500 (Diagnostic 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-2014-RN-00839-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-07-31
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00839-1
  • 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 was an incident overseas where the beta assembly (x-ray tube and collimator) detached from the overhead tube crane (otc) telescope, falling onto the patient who was injured, requiring hospitalisation. no other reports of this type have been received since the device was introduced into commercial distribution in 2005. carestream health has determined that this incident occurred due to the part that holds the beta assembly to the otc telescope not being properly assembled at the time of manufacture.
  • Action
    Carestream Health Australia Pty Ltd is arranging for inspection of all the affected units and will conduct a repair if required. This action has been closed-out on 19/02/2016.

Device

Kodak DirectView DR 7500 (Diagnostic x-ray system)

Manufacturer

Carestream Health Australia Pty Ltd