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
    71318
  • Event Risk Class
    II
  • Event Initiated Date
    2016-10-13
  • 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 patient support table top may fail to move in the horizontal direction when it is commanded to do so during ct scans due to a potential mechanical linkage failure. the system cannot automatically detect this failure to abort the scan or to alert the user. of the 5000 ct systems potentially affected there have been 2 occurrences of this failure mode in the past 10 years.

Device

BRILLIANCE CT BIG BORE SYSTEM - MAIN UNIT
  • Model / Serial
    Model Catalog: 4535 670 88051 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 4550 110 09021 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 4550 110 04011 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 728311 (Lot serial: 200071); Model Catalog: 453567005721 (Lot serial: 6149); Model Catalog: 453567005721 (Lot serial: 6150); Model Catalog: 728306 (Lot serial: 100195); Model Catalog: 728306 (Lot serial: 100223); Model Catalog: 4535 670 78851 (Lot serial: 6352); Model Catalog: 728306 (Lot serial: 100206); Model Catalog: 728306 (Lot serial: 100249); Model Catalog: 728306 (Lot serial: 100101); Model Catalog: 728306 (Lot serial: 100290); Model Catalog: 728306 (Lot serial: 100046); Model Catalog: 728306 (Lot serial: 100440); Model Catalog: 728326 (Lot serial: 30003); Model Catalog: 728326 (Lot serial: 30004); Model Catalog: 728323 (Lot serial: 30004); Model Catalog: 728323 (Lot serial: 320148); Model Catalog: 728326 (Lot serial: 320148); Model Catalog: 728323 (Lot serial: 320123); Model C
  • Product Description
    BRILLIANCE CT BIG BORE SYSTEM - MAIN UNIT;BRILLIANCE 40/64 SLICE CT SYSTEM;BRILLIANCE ICT SP SYSTEM - MAIN;BRILLIANCE CT SYSTEM (16P);BRILLIANCE ICT SYSTEM - SYSTEM;BRILLIANCE 6/10/16 SLICE CT SYSTEM;INGENUITY CT SYSTEM
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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