Events

Recall of BRILLIANCE CT BIG BORE 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
    32304
  • Event Risk Class
    II
  • Event Initiated Date
    2018-01-05
  • 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
    Philips became aware of issues with brilliance big bore ct systems running software version 4.2.0. the most significant issues are: issue #1: efov (extended field of view) check message does not display when fov is set >600mm for a paused scan issue #2: prefer "center x/y 0" and "disable result rotation" checkboxes checked automatically when checking the "ct simulation" issue #3: tumor loc allows poi (point of interest) locking when a non-isocenter slice is displayed issue #4: tracker scan completed no images were generated issue #5: continuous link plans the clinical scan outside the surview issue #6: applying tilt on first mpr result when the other axial results are unplanned causes change in scan length and number of cycles of scan issue #7: "system is still initializing. please wait." error issue #8: auto locations not functioning as expected issue #9: system ended exam before completion issue #10: system freeze-up after pause is pressed (for french translation please see e-file).

Device

BRILLIANCE CT BIG BORE SYSTEM - MAIN UNIT
  • Model / Serial
    Model Catalog: 728244 (Lot serial: N/A)
  • Product Description
    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