Device product
MRIdian¿ ViewRay¿ Radiation Therapy System, ViewRay¿ Is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
Z-0115-2016
Product summary
- Event
- Event 72166
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4 units
- Official record key
device-enforcement:Z-0115-2016
Official wording
Reason: ViewRay discovered that in the event that an encoder breaks or fails on the Patient Handling System (PHS, or couch), when attempting to restart the system, the couch could move unexpectedly.
Code information: Catalog/Part Number: 10000; Serial Numbers: 100, 101, 102, & 105
Distribution pattern: US Distribution to the states of : CA, MO and WI., and Internationally to Korea.
Derived failure modes
-
Unknown
ViewRay discovered that in the event that an encoder breaks or fails on the Patient Handling System (PHS, or couch), when attempting to restart the system, the couch could move unexpectedly.