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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