FDA-Device2019-09-04Class II
Monaco Radiation Treatment Planning System (RTP) System
Elekta, Inc.
Hazard
Monaco is displaying the Anatomy and Beam shift direction incorrectly on the Monaco Scan and Setup Reference Report and is DICOM exporting incorrect (Anatomy/Beam) shift directions.
Sold states
Distribution within the US to Ohio and Indiana. International distribution to Germany, Greece, Sweden.
Affected count
49 units
Manufactured in
400 Perimeter Center Ter NE Ste 50, N/A, Atlanta, GA, United States
Products
Monaco Radiation Treatment Planning System (RTP) System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2409-2019Don't want to check this manually?
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