Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Recalled by Philips Medical Systems Due to In DS/US proton planning, there is a correction...
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 directly.
Affected Products
DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model #459800200621
Quantity: 3
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Philips Medical Systems
Philips Medical Systems has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report