Events

Recall of INTELEPACS Version 3.8.1 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-00662-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-06-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00662-1
  • 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 medical systems inc. following internal testing, is providing additional information regarding the proper usage of the intelepacs software. this issue relates to the compression of images into jpeg 2000 (2c) format. in specific circumstances, when writing image data to storage that has filled up, the image data may become truncated.
  • Action
    In order to correct this issue, a new software release will be installed on affected systems. Intelerad will run an audit on the entire PACS to identify all image data that may be truncated. For any affected studies, Intelerad will be able to restore a full fidelity image if required by the customers. This action has been closed-out on 29/01/2016.

Device

INTELEPACS Version 3.8.1 and up (Radiology picture archiving and communication system)

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia