Events

Recall of BRILLIANCE ICT SP SYSTEM - MAIN

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
    67756
  • Event Risk Class
    II
  • Event Initiated Date
    2018-02-14
  • 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
    Upon closing the emergency stop (e-stop) the system performs an internal check. as a result of the motion controller in the couch there is a delay in the response to the internal check. this delay may cause the couch carbon top to enter a free float state which may allow it to move during patient load or unload activities. this free float motion results in the estop being opened due to the unexpected couch motion. this issue occurs frequently after closing e-stop. the motion controller in the couch detects a power problem and disables the horizontal motor which allows the couch top to free-float*. *the term free float refers to the couch top being in a state that is not locked in position by the brake or being moved in a controlled fashion (manual or automatic motion).

Device

BRILLIANCE ICT SP SYSTEM - MAIN
  • Model / Serial
    Model Catalog: 728311 (Lot serial: N/A); Model Catalog: 4535 670 88051 (Lot serial: N/A); Model Catalog: 728244 (Lot serial: N/A); Model Catalog: 728306 (Lot serial: N/A); Model Catalog: 728326 (Lot serial: N/A); Model Catalog: 728323 (Lot serial: N/A)
  • Product Description
    BRILLIANCE ICT SYSTEM- SYSTEM;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