Events

Recall of Kodak DirectView DR 7500 System with software version 5.3 (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-00031-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-01-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00031-1
  • 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
    There were two incidents in the united states where the previous patient image was displayed on the console with the current patient's name. carestream health has determined that this only occurs when the user interrupts the daily offset refresh detector calibration by switching the active detector from one bucky to another (e.G. table to the wall) and cancels detector calibration within 30 seconds of initiating this process. there have been no reports of misdiagnosis or injuries related to this issue.
  • Action
    Carestream Health is recommending that the daily detector calibration process should not be interrupted once initiated and completed only when patients are not being imaged. Carestream Health is installing the software modification as a permanent correction.

Device

Kodak DirectView DR 7500 System with software version 5.3 (diagnostic x-ray system)

Manufacturer

Carestream Health Australia Pty Ltd