FDA-Device2019-12-18Class II
MRIdian Linac Radiation Therapy System Model 10000 and 20000
Viewray, Inc.
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.
Sold states
US - CA, FL, IL, MI, MO, NY, and WI OUS: Denmark, France, Germany, Italy, Japan, Netherlands, Turkey, South Korea, and UAE
Affected count
24 Systems
Manufactured in
815 E Middlefield Rd, N/A, Mountain View, CA, United States
Products
MRIdian Linac Radiation Therapy System Model 10000 and 20000
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0676-2020Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief