Cl II Elekta Oncentra External Beam

Company: Elekta, Inc.
Date of Enforcement Report 1/18/2017
Class lI:

PRODUCT

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

REASON
Cross profile for Varian 60 degree wedge shows “horns.”

RECALLING FIRM/MANUFACTURER
Elekta inc., Atlanta, GA on 12/23/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
433

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.