DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model #459800200621
This recall has been terminated (originally issued February 2, 2016).
- Company
- Philips Medical Systems
- Recall Initiated
- January 8, 2016
- Posted
- February 2, 2016
- Terminated
- October 5, 2016
- Recall Number
- Z-0745-2016
- Quantity
- 3
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
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
US: Nationwide Distribution in the states of FL, OH, and MO.
Lot / Code Info
Software Version 10.0.0 and 14.0.0
Root Cause
Device Design
Action Taken
Philips sent an "Urgent Medical Device Correction" letter dated 16-DEC-2015 to affected customers. The letter described the Affected Products, Problem Description, Hazard Involved, How to Identify Affected Products, Action to be Taken by Customer / User, Actions Planned by Philips and Further Information and Support (contact Philips Customer Care Solutions Center at 1-800-722-9377 ).