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
    133032
  • Event Risk Class
    III
  • Event Initiated Date
    2016-04-21
  • 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
    Philips has become aware of the following seven software issues: 1.Sagittal result shortened for axial scans 2.Single series displayed in console viewer when creating mpr's. 3.Scan length changes with a change in field of view 4.Different ctdi values with doseright 5.Scan length changes on subsequent axial results 6. surview scan lengths near 135mm or 184mm may result in unexpected scan start positions and 7.Reconstruction length does not equal scan length.

Device

BRILLIANCE ICT SP SYSTEM - MAIN
  • Model / Serial
    Model Catalog: 728311 (Lot serial: all lots); Model Catalog: 4550 110 09021 (Lot serial: all lots); Model Catalog: 728326 (Lot serial: all lots); Model Catalog: 728323 (Lot serial: all lots); Model Catalog: 728306 (Lot serial: all lots)
  • Product Description
    BRILLIANCE ICT SP SYSTEM - MAIN;BRILLIANCE 40/64 SLICE CT SYSTEM;INGENUITY CT SYSTEM;BRILLIANCE ICT SYSTEM - SYSTEM
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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