Events

Recall of BRILLIANCE CT BIG BORE SYSTEM - MAIN UNIT

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
    28907
  • Event Risk Class
    II
  • Event Initiated Date
    2012-01-30
  • 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
    The tumorloc will save the incorrect contour when the user saves the cntour while in the edit mode and that the software does not forice the suer to exit the edit mode before saving. in tumorloc when saving while a contour is in edit mode that contour will shift to the slice corresponding to the most recently drawn controuf of the last organ in the organ list.

Device

BRILLIANCE CT BIG BORE SYSTEM - MAIN UNIT
  • Model / Serial
    Model Catalog: 4535 670 88051 (Lot serial: N/A FOR ALL); Model Catalog: 455011002031 (Lot serial: ); Model Catalog: 4535 679 83931 (Lot serial: ); Model Catalog: 4535 679 71891 (Lot serial: ); Model Catalog: 4535 679 94741 (Lot serial: )
  • Product Description
    BRILLIANCE CT BIG BORE SYSTEM-MAIN UNIT
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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