Events

Recall of DIRECTVIEW Software versions 5.6 & greater and 5.7 with DR LLI Auto Stitch option on DRX Evolution with Premium and Full Featured Wall Stands(Digital 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-2015-RN-00763-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-08-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00763-1
  • 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 has identified a software issue that impacts image alignment when using the automatic stitching option for long length images. if there is no use of external fiducial markers or measurement tools (eg. radiopaque ruler) when building a composite image and the technologist relies solely on the auto stitching software, there is a risk of undetected stitching errors. this may lead to potential diagnosis errors if measurements taken from just that image wererelied on. any injury resulting from this could lead to delays in treatment or the need for further diagnostic imaging techniques.
  • Action
    Whilst there have not been any diagnosis errors reported, Carestream Health is conducting this action to update the software on affected devices to correct this issue. In the interim, Carestream Health recommends that the auto-stitching feature is turned off and the manual stitch editor used to create all composite images until the software update has been made to affected devices. This action has been closed-out on 12/08/2016.

Device

DIRECTVIEW Software versions 5.6 & greater and 5.7 with DR LLI Auto Stitch option on DRX Evolutio...
  • Model / Serial
    DIRECTVIEW Software versions 5.6 & greater and 5.7 with DR LLI Auto Stitch option on DRX Evolution with Premium and Full Featured Wall Stands(Digital X-ray system)ARTG number: 136112
  • Manufacturer
    Carestream Health Australia Pty Ltd

Manufacturer

Carestream Health Australia Pty Ltd