Company: Elekta, Inc.
Date of Enforcement Report 1/18/2017
Oncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiation therapy planning software designed to analyze and plan radiation treatment is three dimensions for the purpose of treating patients with cancer.
Recall Number Z-0987-2017
Cross profile for Varian 60 degree wedge shows “horns.”
Elekta inc., Atlanta, GA on 12/23/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
Nationwide and Internationally