Events

Recall of IntelliSpace Portal software version 4.0.2 (Used to remotely access data from networked computers for diagnostic viewing) used with URL PACS integration

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Philips Electronics Australia Ltd.

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-2013-RN-00223-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-03-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00223-1
  • 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
    When loading a study to an analysis application while using url pacs integration configuration, after another study was opened by a review application, the analysis monitor is updated with the study of the current patient but the review monitor continues to display the study from the previous patient.
  • Action
    Philips Healthcare will be installing a software update to address the above identified issue. As a temporary mitigation, the clinicians have been advised that when reviewing two disparate image datasets, not to only be focused on the actual image content but also to be alerted to the patient’s study name and/or ID prior to interpretation.

Device

IntelliSpace Portal software version 4.0.2 (Used to remotely access data from networked computers...
  • Model / Serial
    IntelliSpace Portal software version 4.0.2 (Used to remotely access data from networked computers for diagnostic viewing) used with URL PACS integration ARTG Number: 188684
  • Product Classification
    Radiology Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    DHTGA