Events

Recall of BRILLIANCE 6/10/16 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
    130152
  • Event Risk Class
    II
  • Event Initiated Date
    2012-09-21
  • 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 ct system phantom supplied with certain scanners has a special pin by which the customer can check the low contrast (lc) detectability for quality assurance. this pin consists of a nylon (aculon) body with six smaller lexan pins of 3mm 4mm 5mm 6mm 7mm and 8mm diameters which have contrast difference of approximately 1% from aculon. the lc test is performed by visually inspecting the section and selecting the smallest detectable lexan pin for a predefined scan protocol as defined in the ifu manual. however the pin visibility deteriorates over time usually a few years. this causes the test to become unreliable and inaccurate. to ensure that low contrast is within specification philips is providing instructions as a guideline to a more reliable check of the image noise on the water layer of the system phantom.

Device

BRILLIANCE 6/10/16 SLICE CT SYSTEM
  • Model / Serial
    Model Catalog: 4535 670 73181 (Lot serial: N/A FOR ALL); Model Catalog: 4535 670 73191 (Lot serial: N/A FOR ALL); Model Catalog: 4535 670 00121 (Lot serial: ); Model Catalog: OFF-EI-590 (Lot serial: )
  • Product Description
    BRILLIANCE 6/10/16 SLICE CT SYSTEM
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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