FDA-Device2019-12-18Class II
Monaco Radiation Treatment Planning System (RTP) System
Elekta Inc
Hazard
Monaco is using the incorrect energy when optimizing and calculating dose.
Sold states
IA, IN, NY, OH, TX, WI. Internationally distributed to: Australia, Canada, China, Denmark, Germany, Greece, Hong Kong, Italy, Netherlands, Sweden, Switzerland, United Kingdom.
Affected count
76 (7 US, 69 OUS)
Manufactured in
1450 Beale St Ste 205, N/A, Saint Charles, MO, United States
Products
Monaco Radiation Treatment Planning System (RTP) System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0670-2020Don't want to check this manually?
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