Company:Elekta, Inc.
Date of Enforcement Report 10/31/12
Class ll:
PRODUCT
Oncentra External Beam 4.1. Radiation treatment planning software designed to analyze and plan radiation treatments in their dimension for the purpose of treating patients with cancer. Recall Number Z-0118-2013
REASON
During the planning process the beam weights can be changed by the customers. When the beam weights are changed and renumbered and this happens during the dose calculation it is possible to save and reopen the plan without any error messages.
RECALLING FIRM/MANUFACTURER
Elekta, Inc., Norcross , GA on 8/21/2012. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
52
DISTRIBUTION
Nationwide
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