Events

Recall of IntelePACS InteleViewer with software version 3-5-1 to 4-15-1

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-2017-RN-01234-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-09-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01234-1
  • 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
    Following a complaint from a client, intelerad is notifying users of a problem that could occur on their intelepacs software. the magnification tool functionality may display incorrect images if the user is utilising reverse ordering. in this instance, the image shown in the tool will not be the one in the current viewport. the tool may be displaying a magnified image for a different slice of the series. this software defect could lead radiologists to delay their diagnosis/report. there have been no injuries reported as a result of this issue.
  • Action
    Emergo is advising users to be aware of this issue. A software correction will be implemented to rectify the issue.

Device

IntelePACS InteleViewer with software version 3-5-1 to 4-15-1

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia