Events

Recall of BRILLIANCE 40/64 SLICE CT SYSTEM - EXTENDED BRILLIANCE WORKSPACE 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
    49105
  • Event Risk Class
    III
  • Event Initiated Date
    2012-09-14
  • 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
    When performing post processing with the brilliance workspace portal platform with software version 2.6.1.4 the coronary arteries in the rendered image are segmented automatically. however the centre line is not extracted or highlighted upon hovering and making it impossible to activate the vessel and choose the appropriate name (label) from the drop-down menu. as a result the operator has to manually extract the relevant vessel using the centerline extraction tools. once extracted it will allow the user to view and label the coronary artery.

Device

BRILLIANCE 40/64 SLICE CT SYSTEM - EXTENDED BRILLIANCE WORKSPACE PORTAL
  • Model / Serial
    Model Catalog: 4550 110 02101 (Lot serial: ); Model Catalog: 4550 110 02101 (Lot serial: N/A FOR ALL)
  • Product Description
    BRILLIANCE 40/64 SLICE CT SYSTEM-EXTENDED BRILLIANCE WORKSPACE PORTAL
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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