Device product
MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc.
Z-0806-2016
Product summary
- Event
- Event 73086
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5 units
- Official record key
device-enforcement:Z-0806-2016
Official wording
Reason: The system loaded a completion fraction in the incorrect order after a treatment interruption.
Code information: Model #: 10000, Serial #'s: 100, 101, 102, 104 & 105
Distribution pattern: US Distribution to the states of : CA, FL, MO & WI., and Internationally to Republic of Korea.
Derived failure modes
-
Unknown
The system loaded a completion fraction in the incorrect order after a treatment interruption.