Recall Z-1643-2015 ยท MUJ System, Planning, Radiation Therapy Treatment
Philips Medical Systems, Inc.
Pinnacle3 Software Version 10.0, Model 459800200841. Product Usage: The Pinnacle 3 RTP software allows qualified medical professionals to enter patient data into the system, use that data to construct a plan for radiation therapy and evaluate the plan. Optionally, the qualified medical personnel may output the plan in an electronic or printed form for use by other systems in the delivery of trea
| Date | May 21, 2015 (initiated Apr 23, 2015) |
| Status | Terminated |
| Reason | A problem (the dose computed in planning mode is calculated incorrectly ) has been detected in the Philips Pinnacle3 software version 10.0 that, if it were to re-occur, could pose a risk for patients or users. Specifically, the dose engine is being passed the wrong snout position. The snout position is used to determine the penumbra of the beam which includes the calculation of the source si |
| Root cause | Software design |
| Action | Philips Healthcare sent a "Field Safety Notification PROST-T-300-01-06" letter dated 20 April 2015 to their customers. The letter described the 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 | 4 |
| Distribution | US Nationwide Distribution in the states of MO, FL, OH |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041577 | PINNACLE3 RADIATION THERAPY PLANNING SYSTEM Adac Laboratories, Jun 25, 2004 |