Device product
Monaco RTP System, 5.50/5.51, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and carbon treatment plans and displays, on-screen and in hard-copy, two- or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups. The Monaco product line is intended for use in radiation treatment planning. It uses generally accepted methods for: -contouring -image manipulation -simulation -image fusion -plan optimization -QA and plan review
Z-2561-2019
Product summary
- Firm
- Elekta Inc
- Event
- Event 83692
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 49 units
- Official record key
device-enforcement:Z-2561-2019
Official wording
Reason: It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.
Code information: UDI: (01)00858164002244(10) 5.50.00 (01)00858164002268(10) 5.51.00
Distribution pattern: Worldwide Distribution - US Nationwide in the states of WI, OH, NY, OH, IN, IA, TX, and countries of Canada, China, Denmark, Germany, Greece, Hong Kong, Italy, Netherlands, Sweden, UK
Derived failure modes
-
Unknown
It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.