Events

Recall of INTELLISPACE PORTAL HX

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
    85367
  • Event Risk Class
    II
  • Event Initiated Date
    2012-05-25
  • 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 has identified software and user issues with specific applications and options running on the intellispace portal (isp) with software version 4.0 or version 4.0.1 that if the issues were to re-occur it could pose a risk for the patient. software issues: 1. when the user chooses to launch different patient studies directly from the pacs archive into portal applications (pacs integration configuration) the system does not warn the user that a different patient study has been selected for viewing. 2. discrepancies in colors and size of the affected area were observed when the customer uses the "time sensitive" and "time insensitive" methods a sub option of the brain perfusion option. user issue: in the multi-modality tumor tracking application discrepancies in lesion measurements were observed when edits were made to the contours and the editing tool was not closed before moving onto another lesion or stage.

Device

INTELLISPACE PORTAL HX
  • Model / Serial
    Model Catalog: 4598 001 30491 (Lot serial: ); Model Catalog: 4598 001 31131 (Lot serial: N/A FOR ALL)
  • Product Description
    INTELLISPACE PORTAL HX
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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