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
    124507
  • Event Risk Class
    II
  • Event Initiated Date
    2015-09-17
  • 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
    Issue 1: image position accuracy - image rotation calibration program performed by field service representative can report pass but fail to produce the correct angular rotation offset value for the ultra-fast scan mode. the inaccurate angular rotation offset can impact the accuracy of radiation treatment planning. issue 2: tracker image artifact - tracker scan image of ct angiography (cta) examination can exhibit a streaking artifact. due to the streaking artifact the automatic clinical scan may be triggered at the wrong time resulting in suboptimal ct diagnostic images that do not capture the bolus peak of the imaged body section. issue 3: ring/dot image artifact due to x-ray measurement - after a complete system power shutdown and power up if a head scan is performed without air calibration and without quick iq check scan after power up intermittent ring/dot image artifacts in the reconstructed images may occur.

Device

BRILLIANCE CT BIG BORE SYSTEM - MAIN UNIT
  • Model / Serial
    Model Catalog: 4535 670 88051 (Lot serial: ALL); Model Catalog: 728323 (Lot serial: ALL)
  • 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