Events

Recall of BRILLIANCE 6/10/16 SLICE CT SYS-SFTWR DENTAL PLANNING

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
    126228
  • Event Risk Class
    II
  • Event Initiated Date
    2009-06-10
  • 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
    When images are saved or filmed that contain the curved multi-planar reformation section (cmprs) while using the dental application v4.0.0 to v4.0.1.9999 on the extended brilliance workspace the right/left annotations will be reversed on views that were created with a short curve.

Device

BRILLIANCE 6/10/16 SLICE CT SYS-SFTWR DENTAL PLANNING
  • Model / Serial
    Model Catalog: 455011202691 (Lot serial: N/A)
  • Product Description
    BRILLIANCE 6/10/16 SLICE CT-SFRTWR DENT
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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