FDA-Device2021-09-08Class II
Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10
Elekta Inc
Hazard
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.
Sold states
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
Affected count
N/A
Manufactured in
1450 Beale St Ste 205, N/A, Saint Charles, MO, United States
Products
Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2406-2021Don't want to check this manually?
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