Events

Recall of ADVANTX LEGACY/LEGACY D R/F SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE).

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
    65178
  • Event Risk Class
    II
  • Event Initiated Date
    2008-04-01
  • 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 the primary protective barrier was removed out of the path of the fluoroscopic x-ray beam x-ray exposures were not inhibited as required by 21 cfr 102032(a).

Device

ADVANTX LEGACY/LEGACY D R/F SYSTEM
  • Model / Serial
    Model Catalog: 2118104 (Lot serial: 989578WK0 986374WK7); Model Catalog: 2118104 (Lot serial: 989800WK8 988508WK8); Model Catalog: 2118104 (Lot serial: 988022WK0 958576WK1); Model Catalog: 2118104 (Lot serial: S/Ns 989776WK0 988114WK5); Model Catalog: 2118104 (Lot serial: 989598WK8 989718WK2); Model Catalog: 2403791 (Lot serial: >10 NUMBERS); Model Catalog: 2403791 (Lot serial: MANUFACTURER); Model Catalog: 2403791 (Lot serial: CONTACT)
  • Product Description
    ADVANTX LEGACY/LEGACY D R/F SYSTEM
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)