Events

Recall of BRILLIANCE 64 SLICE CT 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
    21511
  • Event Risk Class
    II
  • Event Initiated Date
    2013-05-17
  • 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 stated tolerance for ctdi(vol) in the instructions for use manual did not accurately represent all systems. on some systems the measured ctdi(vol) value may fall outside of these stated tolerances.

Device

BRILLIANCE 64 SLICE CT SYSTEM - MAIN UNIT
  • Model / Serial
    Model Catalog: 4550 110 00921 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 4535 679 94741 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 453567005721 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 4535 679 71891 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 4535 679 83931 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 4535 670 78851 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 728306 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 4535 670 73181 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 4550 110 04011 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 2169-3000A (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 45356 790 0891 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 4598 001 18561 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 2169-3002A (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 728311 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 4535 670 88051 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    BRILLIANCE 64 SLICE CT SYSTEM - MAIN UNIT
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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