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
    80894
  • Event Risk Class
    II
  • Event Initiated Date
    2011-12-16
  • 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
    1) when opposing a beam in the beam geometry panel in tumorloc the block and multi leaf collimator (mlc) shape is not propagated to the beam that is modified by the oppose operation. 2) when at least one tumorloc organ is visualized in beam's eye view viewers as "off" and another organ is visualized as "outline" the contours can appear with the incorrect color in the beam's eye view viewer. since the only way to correlate the organ between the toolbar and display is via color this can result in organs being incorrectly placed or incorrectly shaped.

Device

BRILLIANCE CT BIG BORE SYSTEM - MAIN UNIT
  • Model / Serial
    Model Catalog: 4535 670 88051 (Lot serial: N/A)
  • 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