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Viewray, Inc. recalls MRIdian Linac Radiation Therapy System Model 10000 and 20000
Recalled December 18, 2019 · FDA recall Z-0676-2020 · Viewray
Hazard
Issue with transferring treatment regiment from one system to another. Adequate instructions for transferring treatment plan(s) are not provided within the operator's manual or within the software operating system. · FDA Class II
Units
24 Systems
Sold at
US - CA, FL, IL, MI, MO, NY, and WI OUS: Denmark, France, Germany, Italy, Japan, Netherlands, Turkey, South Korea, and UAE
Description
Issue with transferring treatment regiment from one system to another. Adequate instructions for transferring treatment plan(s) are not provided within the operator's manual or within the software operating system.
Product
MRIdian Linac Radiation Therapy System Model 10000 and 20000
Manufacturer(s)
Viewray, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →