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Elekta Inc recalls Monaco Radiation Treatment Planning System (RTP) System
Recalled December 18, 2019 · FDA recall Z-0670-2020 · Elekta
Hazard
Monaco is using the incorrect energy when optimizing and calculating dose. · FDA Class II
Units
76 (7 US, 69 OUS)
Sold at
IA, IN, NY, OH, TX, WI. Internationally distributed to: Australia, Canada, China, Denmark, Germany, Greece, Hong Kong, Italy, Netherlands, Sweden, Switzerland, United Kingdom.
Description
Monaco is using the incorrect energy when optimizing and calculating dose.
Product
Monaco Radiation Treatment Planning System (RTP) System
Manufacturer(s)
Elekta Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →