FDA recall Z-0670-2020

Product

Monaco Radiation Treatment Planning System (RTP) System

Reason for recall

Monaco is using the incorrect energy when optimizing and calculating dose.

Distribution

IA, IN, NY, OH, TX, WI. Internationally distributed to: Australia, Canada, China, Denmark, Germany, Greece, Hong Kong, Italy, Netherlands, Sweden, Switzerland, United Kingdom.

Key facts

Status

Ongoing

Initiation date

2019-11-22

Report date

2019-12-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Saint Charles, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0670-2020