Device product
Monaco Radiation Treatment Planning System (RTP) System
Z-0670-2020
Product summary
- Firm
- Elekta Inc
- Event
- Event 84330
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 76 (7 US, 69 OUS)
- Official record key
device-enforcement:Z-0670-2020
Official wording
Reason: Monaco is using the incorrect energy when optimizing and calculating dose.
Code information: Software Builds: 5.40.00, 5.50.00 and 5.51.00. UDI GTIN: (01)00858164002190(10) 5.40.00, (01)00858164002244(10) 5.50.00, and (01)00858164002268(10) 5.51.00
Distribution pattern: IA, IN, NY, OH, TX, WI. Internationally distributed to: Australia, Canada, China, Denmark, Germany, Greece, Hong Kong, Italy, Netherlands, Sweden, Switzerland, United Kingdom.
Derived failure modes
-
Unknown
Monaco is using the incorrect energy when optimizing and calculating dose.