Z-0745-2016 Class II Terminated
FDA device recall Z-0745-2016 was initiated by Philips Medical Systems on January 8, 2016 and is designated Class II. 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. The recall status is terminated (terminated October 5, 2016). Affected quantity: 3.
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