Device product
MRIdian Linac Radiation Therapy System, Model 20000.
Z-1251-2019
Product summary
- Firm
- Viewray, Inc.
- Event
- Event 82612
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17 devices
- Official record key
device-enforcement:Z-1251-2019
Official wording
Reason: A discrepancy between optimization and planning forward dose calculation between adaptive optimizations and AQA dose calculations can occur.
Code information: Serial Numbers 101,107, 201, 202, 203, 204, 205, 206, 209, 211, 213, 214, 217, 221, 223, 225, 228.
Distribution pattern: 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,
Derived failure modes
-
Unknown
A discrepancy between optimization and planning forward dose calculation between adaptive optimizations and AQA dose calculations can occur.