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Elekta Inc recalls Monaco RTP System, 5.40 Unity, radiation treatment planning system Product Usage: The Monaco system is used to make
Recalled October 2, 2019 · FDA recall Z-2560-2019 · Elekta
Hazard
It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation. · FDA Class II
Units
30 units
Sold at
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
Description
It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.
Product
Monaco RTP System, 5.40 Unity, 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
Manufacturer(s)
Elekta Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →