Events

Recall of INTELEPACS Versions 4.5.1 to 4.12.1(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-2016-RN-00346-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-04-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00346-1
  • 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
    Due to the asynchronous nature of image ingestion processing, a failure at the early stages of the ingestion process may occur leading to images not being visible to the end user, without any indication to the user that this has occurred.The user may not be aware that images might be missing. a misdiagnosis or a delay in diagnosis and treatment can occur if health professionals base their diagnosis on incomplete image sets.
  • Action
    In order to correct this problem, Intelerad is: 1- providing concerned clients with a list of affected studies and possibly recover the missing images; 2- deploying a software update that includes both a fix and a mitigation for all clients potentially affected by the problem; and 3- periodically auditing all concerned client systems to find and report to the concerned client any new occurrences of this problem until the software update is in place. This action has been closed-out on 27/01/2017.

Device

INTELEPACS Versions 4.5.1 to 4.12.1(Radiology picture archiving and communication system)
  • Model / Serial
    INTELEPACS Versions 4.5.1 to 4.12.1(Radiology picture archiving and communication system) Affected software identifier contains an “R” but with a number below the following:PACS-4-5-1-R77PACS-4-6-1-R85PACS-4-8-1-R46PACS-4-10-1-R36PACS-4-11-1-R28PACS-4-12-1-R4ARTG Number: 149923
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia