Philips Pinnacle3 Software Version 10.0 Cl II

Company: Philips Medical Systems, Inc.
Date of Enforcement Report 6/3/2015
Class lI:

PRODUCT

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 treatment to a patient. Recall Number Z-1643-2015

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 size and the calculation of the compensator scatter. The actual snout position is shown in the planning window as X, but the value passed to the dose engine is Y, where Y=X + (unmilled compensator thickness  physical thickness of compensator). The unmilled compensator thickness is defined in physics mode and is usually around 20-30 cm. In rare situations, this translates into an error in the calculation of the penumbra that in some cases, goes beyond the limits of our specification. The issue only exists in planning mode. In physics mode we do not have this issue because the mechanism for sending the snout position to the dose engine is different in physics than in planning mode. Thus the dose computed in planning mode is different than the dose computed in physics mode. The issue is most pronounced for beams that do not have compensators or where the milled compensator is relatively thin compared to the unmilled compensator.

RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Inc., Andover, MA 4/23/2015. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
4

DISTRIBUTION
US Nationwide Distribution in the states of MO, FL, OH

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