Events

Recall of BRILLIANCE 40/64 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
    42652
  • Event Risk Class
    III
  • Event Initiated Date
    2016-05-02
  • 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
    Imr cardiac - irregular appearance of contrast in vessels missing image annotation's in cct halo artifacts incorrect z annotation on plan box for coronal/sagittal surviews unintended change of acquisition timing on scan ruler bolus tracker does not trigger as expected system unresponsive when paused system becomes unresponsive during timed scan unplanned results during multi-phase pulmo series may cause a system crash communication errors between host computer & gantry incorrect phase tolerance for cardiac step & shoot error when auto roi placement outside patient anatomy no "go" when hr outside of acceptable range console unresponsive when gantry cancels scan unable to match z locations on prescan and 4d ct scan pin wheel artifact using 0.67mm slice width tracker scan halted with fdom. (please contact manufacturer for details regarding reasons for recall).

Device

BRILLIANCE 40/64 SLICE CT SYSTEM
  • Model / Serial
    Model Catalog: 4550 110 09021 (Lot serial: ALL); Model Catalog: 728311 (Lot serial: ALL); Model Catalog: 728326 (Lot serial: ALL); Model Catalog: 728323 (Lot serial: ALL); Model Catalog: 728306 (Lot serial: ALL)
  • Product Description
    BRILLIANCE 40/64 SLICE CT SYSTEM;BRILLIANCE ICT SP SYSTEM-MAIN;INGENUITY CT SYSTEM;BRILLIANCE ICT SYSTEM-SYSTEM
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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