Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Pinnacle3 Software Version 10.0 Recalled by Philips Medical Systems, Inc. Due to A problem (the dose computed in planning mode...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Philips Medical Systems, Inc. directly.
Affected Products
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.
Quantity: 4
Why Was This Recalled?
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
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Philips Medical Systems, Inc.
Philips Medical Systems, Inc. has 65 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report