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Viewray, Inc. recalls MRIdian Linac Radiation Therapy System, Model 20000.
Recalled May 8, 2019 · FDA recall Z-1251-2019 · Viewray
Hazard
A discrepancy between optimization and planning forward dose calculation between adaptive optimizations and AQA dose calculations can occur. · FDA Class II
Units
17 devices
Sold at
Distribution was made to FL, IL, MI, MO, NY, and WI. There was no government/military distribution. Foreign distribution was made to Denmark, France, Germany, Netherlands, South Korea, Switzerland, Turkey, UAE,
Description
A discrepancy between optimization and planning forward dose calculation between adaptive optimizations and AQA dose calculations can occur.
Product
MRIdian Linac Radiation Therapy System, Model 20000.
Manufacturer(s)
Viewray, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →