Events

Recall of IntelePACS InteleViewer software 4-10-1 and earlier versions (Picture archiving and communication system for radiology)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

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-01045-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-08-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01045-1
  • 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 image fusion functionality may display an incorrect calculation of standard uptake value (suv) when loading the presentation state of image for a previously calculated (and saved) region of interest (roi). this software defect could lead radiologists to base their diagnosis/report on erroneous anatomical measurement leading to incorrect medical treatment.To date, there have been no reports of patient incidents.
  • Action
    Emergo is advising users to confirm the software version installed on their IntelePACS system and if the version is 4-10-1 or earlier, to authorise Intelerad to install an upgrade to InteleViewer 4-11-1 or later. Users are advised to stop using the presentation states functionality of the Image Fusion module until they have InteleViewer 4-11-1 or later installed on their workstation. This action has been closed-out on 02/03/2017.

Device

IntelePACS InteleViewer software 4-10-1 and earlier versions (Picture archiving and communication...

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia