FDA-Device2019-03-06Class II
Monaco Radiation Treatment Planning (RTP) System
Elekta, Inc.
Hazard
If Improve Target Dose was chosen as an optimization model in a previous treatment session, Monaco¿ will automatically use this optimization model again when proceeding with the online plan adaptation of a completion plan when it should not.
Sold states
Domestic distribution to Wisconsin, Texas. International distribution to Denmark, England, Germany, Netherlands, Sweden.
Affected count
14 devices
Manufactured in
400 Perimeter Center Ter NE Ste 50, Atlanta, GA, United States
Products
Monaco Radiation Treatment Planning (RTP) System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0965-2019Don't want to check this manually?
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