Events

Recall of Horizon Medical Imaging (HMI) products software versions 4.5 to and including 11.9 (Radiology picture archiving and communication system)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Device Technologies 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-00101-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-01-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00101-1
  • 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
    During the archive procedure, if the system begins to archive images for multiple studies within fractions of a second and an unexpected condition causes the software process restart the following issues may occur:1. incorrect images being displayed for a study retrieved from archive (for example, a study for a different patient being displayed),2. failure to retrieve images for a study from archive.If this issue occurs, two or more studies may be affected. this issue is not immediately evident to the user at the time of archival. it is possible that clinical decisions will be made using an incorrect set of images or an incomplete set of images. this may result in inappropriate care leading to patient harm if unnoticed or a need to retake images.
  • Action
    Device Technologies is providing users with work around instructions to follow as an interim measure. A software upgrade will be implemented as a permanent correction.

Device

Horizon Medical Imaging (HMI) products software versions 4.5 to and including 11.9 (Radiology pic...

Manufacturer

Device Technologies Australia Pty Ltd