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Elekta, Inc. recalls Monaco Radiation Treatment Planning (RTP) System
Recalled March 6, 2019 · FDA recall Z-0965-2019 · Elekta
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. · FDA Class II
Units
14 devices
Sold at
Domestic distribution to Wisconsin, Texas. International distribution to Denmark, England, Germany, Netherlands, Sweden.
Description
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.
Product
Monaco Radiation Treatment Planning (RTP) System
Manufacturer(s)
Elekta, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →