FDA recall Z-2406-2021

Product

Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10

Reason for recall

If a couch is removed while a plan is loaded, and then added back to the Studyset when the plan is unloaded, it is possible to calculate dose with the couch unassigned to the beams.

Distribution

Distribution in US - IA, NJ, NY, TN, PA, TX, and WI OUS distribution in Australia, Bahrain, Belgium, Canada, China, Denmark, France, Germany, Hong Kong, Italy, Japan, Korea, Netherlands, Spain, Sweden, Switzerland, Thailand, Turkey and United Kingdom

Key facts

Status

Ongoing

Initiation date

2021-07-26

Report date

2021-09-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Saint Charles, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2406-2021