FDA recall Z-2091-2019

Product

Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System

Reason for recall

When creating 3D plans using either MU or Dose weighting modes, if the user changes the number of fractions, rescales the plan and then changes the wedge angle, the Monitor Units are scaled incorrectly.

Distribution

worldwide

Key facts

Status

Ongoing

Initiation date

2019-07-03

Report date

2019-08-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Maryland Heights, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2091-2019