Events

Recall of Horizon Medical Imaging Products Versions 4.6.1 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-00689-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-06-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00689-1
  • 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
    Mckesson has identified a rare software issue when two or more processes attempt to modify the same image folder within fractions of a second, the write lock mechanism may fail to prevent concurrent modification of the same data. this may result in loss of data within the image folder. as both simultaneous write access and lock mechanism failures are rare, the likelihood of experiencing this problem is very low.
  • Action
    The manufacturer, McKeeson Medical Imaging, will provide a software update to resolve this issue. Until the issue is resolved end users are advised to ensure that all expected images are present in a study prior to completing the Technologist workflow. Thia action has been closed-out on 28/01/2016

Device

Horizon Medical Imaging Products Versions 4.6.1 up to and including 11.9 and McKesson Radiology 1...
  • Model / Serial
    Horizon Medical Imaging Products Versions 4.6.1 up to and including 11.9 and McKesson Radiology 12.0 (Radiology picture archiving and communication system)ARTG Number: 158895
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd