Cl II Elekta Oncentra Brachy Software

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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Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.