medical Class II Updated 2019-09-04

Elekta, Inc. recalls Monaco Radiation Treatment Planning System (RTP) System

Recalled Product

Monaco Radiation Treatment Planning System (RTP) System


Hazard / Issue

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.

Issued by

FDA

Distribution: Distribution within the US to Ohio and Indiana. International distribution to Germany, Greece, Sweden.
Lot/Code Info: Software Build: 5.50.00 & 5.51.00; UDI GTIN: (01)00858164002244(10) 5.50.00, (01)00858164002268(10) 5.51.00
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