Device product
Treatment Planning and Delivery System Software version 3.6. ViewRay. Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
Z-1954-2015
Product summary
- Event
- Event 71505
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3
- Official record key
device-enforcement:Z-1954-2015
Official wording
Reason: The software was failing to determine new patient locations if imaging is not enabled during treatment.
Code information: Catalog/Part Number: 10000; Serial #'s: 100, 101, and 102
Distribution pattern: Distributed in the states of CA, MO & WI.
Derived failure modes
-
Unknown
The software was failing to determine new patient locations if imaging is not enabled during treatment.