Company:Elekta, Inc.
Date of Enforcement Report: 10/14/2015
Class lI:
PRODUCT
Monaco Radiation Treatment Planning System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Recall Number Z-0112-2016
REASON
Dose and MU are incorrect when CT images are viewed from the head, and, when using multiple prescriptions with forced densities..
RECALLING FIRM/MANUFACTURER
Elekta, Inc., Altanta, GA on 9/15/2015 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
154 units
DISTRIBUTION
Nationwide and Internationally.
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