Cl II Elekta Monaco RTP System

Company: Elekta, Inc.
Date of Enforcement Report 1/18/2017
Class lI:

PRODUCT

Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Recall Number Z-1009-2017

REASON
Incorrect Enhanced Dynamic Wedge (EDW) or Virtual Wedge (VW) Calculations.

RECALLING FIRM/MANUFACTURER
Elekta inc., Atlanta, GA on 12/21/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
279

DISTRIBUTION
Nationwide and Internationally

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Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.