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.
Enforcement
- Recall Number
- Z-1643-2015
- Event ID
- 71117
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Philips Medical Systems, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 27, 2015
- Initiation Date
- April 23, 2015
- Classification Date
- May 21, 2015
- Termination Date
- October 5, 2016
- Address
- 3000 Minuteman Rd, N/A, Andover, MA, 01810-1032, United States
Description
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.
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
"System Code S/N" 1439NML05A, 1117FMM025, DC090775040, 1117FMM03J.
US Nationwide Distribution in the states of MO, FL, OH
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