Company: Elekta Inc.
Date of Enforcement Report 6/3/2015
Oncentra Brachy radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. Recall Number Z-1712-2015
Incorrect dose calculation for Regions of Interest (ROIs) defined on a secondary image series.
Elekta Inc., Atlanta, GA on 5/21/2015. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
Nationwide and Internationally