Events

Recall of INGENUITY 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
    15694
  • Event Risk Class
    II
  • Event Initiated Date
    2016-08-29
  • 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 that while performing high resolution head scans the reconstructed images may exhibit degraded image quality manifested as: - non uniformity of the image - ct number shift greater than 5 hounsfield units - reduction in gray/white matter differentiation the issue is most severe in the high resolution mode. philips provides factory reference pediatric scan protocols which are set to high resolution by default. adult head scans have a factory reference protocol that defaults to standard resolution which does not experience the issue.

Device

INGENUITY CT SYSTEM
  • Model / Serial
    Model Catalog: 728323 (Lot serial: 32021); Model Catalog: 728326 (Lot serial: 320123); Model Catalog: 728323 (Lot serial: 320123); Model Catalog: 728326 (Lot serial: 320227); Model Catalog: 728326 (Lot serial: 32021); Model Catalog: 728326 (Lot serial: 30003); Model Catalog: 728323 (Lot serial: 30003); Model Catalog: 728326 (Lot serial: 30004); Model Catalog: 728323 (Lot serial: 30004); Model Catalog: 728323 (Lot serial: 320227); Model Catalog: 4550 110 09021 (Lot serial: 10213); Model Catalog: 4550 110 09021 (Lot serial: 9074); Model Catalog: 4550 110 09021 (Lot serial: 9920); Model Catalog: 4550 110 09021 (Lot serial: 9923)
  • Product Description
    INGENUITY CT SYSTEM;BRILLIANCE 40/64 SLICE CT SYSTEM
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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