Z-0745-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 10, 2016
- Initiation Date
- January 8, 2016
- Termination Date
- October 5, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3
Product Description
DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model #459800200621
Reason for Recall
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.
Distribution Pattern
US: Nationwide Distribution in the states of FL, OH, and MO.
Code Information
Software Version 10.0.0 and 14.0.0