Events

Recall of INTELLISPACE PORTAL DX

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PHILIPS ELECTRONICS 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
    17378
  • Event Risk Class
    II
  • Event Initiated Date
    2013-02-15
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Philips healthcare has become aware that a software issue may cause misdiagnosis when using the uniform resource locator (url) pacs integration. 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.

Device

INTELLISPACE PORTAL DX
  • Model / Serial
    Model Catalog: 4598 001 31131 (Lot serial: 85104); Model Catalog: 4598 001 31131 (Lot serial: 81165); Model Catalog: 4598 001 31131 (Lot serial: 85180)
  • Product Description
    INTELLISPACE PORTAL DX
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

PHILIPS ELECTRONICS LTD.
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    HC