Company:Elekta, Inc.
Date of Enforcement Report 2/27/2013
Class ll:
PRODUCT
Monaco RTP System. Radiation treatment planning.
Recall Number Z-0841-2013
REASON
The beam is displayed at the “gantry” angle, but the dose is calculated at the “rotation_start” angle.
RECALLING FIRM/MANUFACTURER
Elekta, Inc., Atlanta, GA,I on 2/11/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
13
DISTRIBUTION
Nationwide
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