Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions...
FDA Recall #Z-1009-2017 — Class II — December 21, 2016
Product Description
Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Reason for Recall
Incorrect Enhanced Dynamic Wedge (EDW) or Virtual Wedge (VW) Calculations.
Recalling Firm
Elekta, Inc. — Atlanta, GA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
279
Distribution
Worldwide Distribution - US Nationwide in the state of CA, IN, KY, MA, NJ, NY, NC, PA, TX, WI, and the countries of Brazil, Canada, China, Croatia, Estonia, Germany, India, Japan, Netherlands, New Zealand, Norway, Poland, Serbia, South Africa, Spain, Russia, Turkey
Code Information
Software Versions 5.00 and higher
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated