Device product
DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model #459800200621
Z-0745-2016
Product summary
- Event
- Event 73023
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3
- Official record key
device-enforcement:Z-0745-2016
Official wording
Reason: In DS/US proton planning, there is a correction factor used internally to the dose engine that is calculating improperly in some cases. This can result in an incorrect dose calculation.
Code information: Software Version 10.0.0 and 14.0.0
Distribution pattern: US: Nationwide Distribution in the states of FL, OH, and MO.
Derived failure modes
-
Unknown
In DS/US proton planning, there is a correction factor used internally to the dose engine that is calculating improperly in some cases. This can result in an incorrect dose calculation.