FDA recall Z-2409-2019

Product

Monaco Radiation Treatment Planning System (RTP) System

Reason for recall

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2019-08-23

Report date

2019-09-04

Termination date

2024-06-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Atlanta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2409-2019