Events

Recall of Horizon Medical Imaging products versions 4.5 up to and including 11.9 and McKesson Radiology 12.0 (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-00610-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-06-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00610-1
  • 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
    The manufacturer, mckesson has identified a software issue which may cause a discrepancy between the index of images expected by the application, and the actual content of the folder storing the images. this discrepancy occurs on a very small percentage of studies, and may result in the following:- a small number of images, typically a single image, in an individual study may be lost or unavailable; and/or- the study is not archived in long-term storage without manual correction of the discrepancy.If the issue occurs, it is possible that clinical decisions will be made using an incomplete set of images. this may result in inappropriate care leading to patient harm and/or a need to retake images.
  • Action
    McKesson will provide a resolution to this issue through a software update which may require changing your software version. A Device Technology Australia representative will contact customers to organise the software upgrade. Thia action has been closed-out

Device

Horizon Medical Imaging products versions 4.5 up to and including 11.9 and McKesson Radiology 12....
  • Model / Serial
    Horizon Medical Imaging products versions 4.5 up to and including 11.9 and McKesson Radiology 12.0 (Radiology picture archiving and communication system)ARTG Number: 158895 (TBC)
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd