Events

Recall of BRILLIANCE 64 SLICE CT SYSTEM - EXTENDED BRILLIANCE WORKSPACE (EBW)

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
    95099
  • Event Risk Class
    II
  • Event Initiated Date
    2010-11-26
  • 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 displayed values in the cca application for the extended brilliance workspace should be labeled as being the percentage of increase in the wall thickness between the end diastolic and the end systolic states but what is actually being displayed is the decrease in wall thickness from the end systolic to the end diastolic state.

Device

BRILLIANCE 64 SLICE CT SYSTEM - EXTENDED BRILLIANCE WORKSPACE (EBW)
  • Model / Serial
    Model Catalog: 4550 110 02031 (Lot serial: 80338); Model Catalog: 4550 110 02031 (Lot serial: 7379); Model Catalog: 4550 110 02101 (Lot serial: 80025); Model Catalog: 4550 110 02031 (Lot serial: 11019); Model Catalog: 4550 110 02101 (Lot serial: 80588); Model Catalog: 4550 110 02101 (Lot serial: 80662); Model Catalog: 4550 110 02101 (Lot serial: 80063); Model Catalog: 4550 110 02101 (Lot serial: 80258)
  • Product Description
    BRILLIANCE 64 SLICE CT SYSTEM - EXTENDED BRILLIANCE WORKSPACE(EBW)
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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