Device product
ONCOR Impression Plus, Digital Linear Accelerator, Model No. 05857912 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
Z-1401-2018
Product summary
- Event
- Event 79766
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15
- Official record key
device-enforcement:Z-1401-2018
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: 3855 4019 4067 3953 5148 3793 5098 5222 3801 5388 3948 3755 5033 4015 5095
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.