Company: Elekta Inc.
Date of Enforcement Report 6/3/2015
Class lI:
PRODUCT
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
REASON
Incorrect dose calculation for Regions of Interest (ROIs) defined on a secondary image series.
RECALLING FIRM/MANUFACTURER
Elekta Inc., Atlanta, GA on 5/21/2015. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
351
DISTRIBUTION
Nationwide and Internationally
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