Events

Recall of INTELLISPACE PORTAL

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
    20539
  • Event Risk Class
    II
  • Event Initiated Date
    2014-07-30
  • 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
    There are software issues in the affected product. 1-when reopening a bookmark generated from processing a muga (multi-gated acquisition) scan within the nm cardiac application the ejection fraction (ef) may be different. 2-when processing using one of the following nm clinical applications: autoquant emory cardiac toolbox corridor4dm or neuroq the patient study presented to the reviewing physician within the application may be for a different patient than the one selected from the patient directory. note: the data presented to the reviewing physician is the data for the patient presented by the application labeling. 3-while using the nm viewer application an arrow annotation added to a display moves away from its original position if the viewer is subsequently maximized or if the image within the viewer is subsequently zoomed in or out. 4-while displaying pet images within ct viewer the suv results displayed may be calculated with an suv method different from the one specified in system preferences. this issue affects the ct viewer and multi-modality tumor tracking applications.

Device

INTELLISPACE PORTAL
  • Model / Serial
    Model Catalog: 4598 003 15411 (Lot serial: N/A); Model Catalog: 4598 003 56911 (Lot serial: N/A); Model Catalog: 4598 001 31111 (Lot serial: N/A); Model Catalog: 4598 001 30491 (Lot serial: N/A)
  • Product Description
    INTELLISPACE PORTAL
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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