Events

Recall of Horizon Medical Imaging (HMI) product versions 4.6.1 up to and including 11.9 and McKesson Radiology (MR) 12.0 and 12.1.1(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-2016-RN-00226-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-03-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00226-1
  • 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
    It has been identified that under rare circumstances, imported images and/or studies may re-use a non-unique image directory.This issue may cause incorrect images to be displayed for a patient. it is possible that clinical decisions will be made using an incorrect set of images. if undetected, in the worst case this may result in inappropriate care leading to potential patient harm.
  • Action
    The sponsor DTA will contact the affected customers and arrange for the implementation of a software upgrade which will resolve the reported issue.

Device

Horizon Medical Imaging (HMI) product versions 4.6.1 up to and including 11.9 and McKesson Radiol...
  • Model / Serial
    Horizon Medical Imaging (HMI) product versions 4.6.1 up to and including 11.9 and McKesson Radiology (MR) 12.0 and 12.1.1(Radiology Picture archiving and communication system)ARTG Number: 158895
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd