Recall Z-0745-2016 ยท IYE Accelerator, Linear, Medical
Philips Medical Systems
DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model #459800200621
| Date | Feb 2, 2016 (initiated Jan 8, 2016) |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | 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 ). |
| Quantity | 3 |
| Distribution | US: Nationwide Distribution in the states of FL, OH, and MO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130992 | PINNACLE3 RADIATION THERAPY PLANNING SYSTEM Philips Medical Systems (Cleveland), Inc., Jun 14, 2013 |