Events

Recall of LOGICON CARIES DETECTOR SOFTWARE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by GA INDUSTRIES.

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
    32043
  • Event Risk Class
    II
  • Event Initiated Date
    2015-11-23
  • 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
    T was determined that changes made to logicon caries detector software version 5.0.22.4 which was distributed to users required regulatory approval before distribution.

Device

LOGICON CARIES DETECTOR SOFTWARE
  • Model / Serial
    Model Catalog: 5.0.22.4 (Lot serial: Serial #s); Model Catalog: 5.0.22.4 (Lot serial: 120001 to 120825)
  • Product Description
    Logicon Caries Detector Software 5.022.4
  • Manufacturer
    GA INDUSTRIES

Manufacturer

GA INDUSTRIES
  • Manufacturer Address
    RANCHO PALOS VERDES
  • Source
    HC