Company: Elekta, Inc.
Date of Enforcement Report 1/18/2017
Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Recall Number Z-1009-2017
Incorrect Enhanced Dynamic Wedge (EDW) or Virtual Wedge (VW) Calculations.
Elekta inc., Atlanta, GA on 12/21/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
Nationwide and Internationally