Device product
MEVATRON M2 / PRIMUS Mid-Energy, Digital Linear Accelerator, Model No. 01940035 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
Z-1397-2018
Product summary
- Event
- Event 79766
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18
- Official record key
device-enforcement:Z-1397-2018
Official wording
Reason: Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table.
Code information: Serial no: 3383 5474 3296 3591 3618 3103 3986 3629 3136 70-4323 5092 3639 3274 2855 3644 4018 70-4347 3939
Distribution pattern: Worldwide Distribution- US Nationwide in the states: AL, CA, FL, GA, IL, IN, KY, MA, MI, MO, MS, NJ, NY, OH, OK, PA, RI, SC, TN, TX, WI, WV, and WY; and PR. International distribution to Nassau.
Derived failure modes
-
Unknown
Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table.