Events

Recall of INTELEVIEWER Versions 3.8.1 P355 and up (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 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-2014-RN-00292-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-03-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00292-1
  • 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
    Intelerad recently discovered a software defect where if you view reports in inteleviewer, you will not see the symbol "<" if it was used in the report. if you view reports in the ris, in intelebrowser, or in inteleconnect, you will see the proper version of the report with the "<" symbol if it was used.
  • Action
    Emergo Australia will contact their customers to arrange for a software update as soon as the update is complete. End users are advised to view reports in the RIS, in InteleBrowser or in InteleConnect until the software problem is corrected. A customers account manager will be in contact immediately to disable to affected feature.

Device

INTELEVIEWER Versions 3.8.1 P355 and up (radiology picture archiving and communication system)

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia