Company: Elekta, Inc.
Date of Enforcement Report 1/13/2016
Class lI:

PRODUCT

Oncentra External Beam – VMAT – Radiation therapy planning system Product Usage: The Oncentra system is a radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.
Recall Number Z-0604-2016

REASON
When using the option “Tumor Overlap Fraction” in VMAT planning it has been observed that in rare cases the system does include an organ at risk as target volume. This could result in open MLC, and open jaws in areas away from the target volume.

RECALLING FIRM/MANUFACTURER
Elekta Inc., Altanta, GA on 12/18/2015. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
154

DISTRIBUTION
Worldwide

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