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Elekta, Inc. recalls Monaco Radiation Treatment Planning System (RTP) System
Recalled September 4, 2019 · FDA recall Z-2409-2019 · Elekta
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. · FDA Class II
Units
49 units
Sold at
Distribution within the US to Ohio and Indiana. International distribution to Germany, Greece, Sweden.
Description
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.
Product
Monaco Radiation Treatment Planning System (RTP) System
Manufacturer(s)
Elekta, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →