FDA recall Z-0965-2019

Product

Monaco Radiation Treatment Planning (RTP) System

Reason for recall

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.

Distribution

Domestic distribution to Wisconsin, Texas. International distribution to Denmark, England, Germany, Netherlands, Sweden.

Key facts

Status

Terminated

Initiation date

2019-02-08

Report date

2019-03-06

Termination date

2024-08-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Atlanta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0965-2019