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

Recall date

August 23, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2409-2019

FDA classification

Class II

Brand / firm

Elekta, Inc.

Sold / distributed

Distribution within the US to Ohio and Indiana. International distribution to Germany, Greece, Sweden.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Monaco Radiation Treatment Planning System (RTP) System