Events

Recall of BRILLIANCE 6/10/16 SLICE CT SYSTEM

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
    54444
  • Event Risk Class
    II
  • Event Initiated Date
    2008-05-29
  • 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 certain reconstructive filters are usedthere can be an increase in hounsfield unit values. hu measurements on images reconstructed with these particular filters should not be used as a diagnostic indicato.

Device

BRILLIANCE 6/10/16 SLICE CT SYSTEM
  • Model / Serial
    Model Catalog: 4535 670 73181 (Lot serial: ); Model Catalog: 4535 670 78851 (Lot serial: ); Model Catalog: 453567005721 (Lot serial: ); Model Catalog: 4535 670 88051 (Lot serial: ); Model Catalog: 4550 11004011 (Lot serial: )
  • Product Description
    BRILLIANCE 6/10/16 SLICE CT SYSTEM
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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