Events

Recall of BRILLIANCE 40/64 SLICE CT SYSTEM - EXTENDED BRILLIANCE WORKSPACE

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
    48206
  • Event Risk Class
    II
  • Event Initiated Date
    2007-12-19
  • 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
    If operator uses the distance or area measurement functions on zoomed and batched saved images from the cardiac or pulmonary viewer and views in the ct viewer or pacs system the measurements will be incorrect.

Device

BRILLIANCE 40/64 SLICE CT SYSTEM - EXTENDED BRILLIANCE WORKSPACE
  • Model / Serial
    Model Catalog: 4550 110 02031 (Lot serial: SN>10 CONTACT MANUFACTURER); Model Catalog: 4550 110 00921 (Lot serial: SN>10 CONTACT MANUFACTURER); Model Catalog: 4550 11004011 (Lot serial: 9138); Model Catalog: 4550 11004011 (Lot serial: 9203); Model Catalog: 4535 670 78851 (Lot serial: SN>10 CONTACT MANUFACTURER); Model Catalog: 4535 670 73191 (Lot serial: SN>10 CONTACT MANUFACTURER); Model Catalog: 4535 670 73181 (Lot serial: SN>10 CONTACT MANUFACTURER); Model Catalog: 4550 11004011 (Lot serial: 9207); Model Catalog: 4550 11004011 (Lot serial: 9164); Model Catalog: 4550 11004011 (Lot serial: 9200); Model Catalog: 4550 11004011 (Lot serial: 9186); Model Catalog: 4535 670 88051 (Lot serial: SN>10 CONTACT MANUFACTURER)
  • Product Description
    BRILLIANCE 40/60 SLICE CT SYSTEM - EWB
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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