Philips Pinnacle 3 Radiation Planning Software May Provide Incorrect Dose Calculations
Philips is recalling Pinnacle 3 radiation therapy planning software due to a software bug that may provide incorrect stopping power ratio calculations. Affected users should contact the manufacturer and verify treatment plans.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall of radiation therapy planning software that may provide incorrect dose calculations, creating a risk of harm to patients. Although no illnesses or injuries have been reported, this qualifies as a risk-of-harm product where injury has not yet been reported per the severity rubric.
Plain-English summary
Philips Medical Systems is recalling 149 units of Pinnacle 3 with TumorLOC Radiation Therapy Planning System Software (Software Version 18.0.5) due to a software issue that may cause the system to provide incorrect dataset calculations when performing stopping power ratio (SPR) calculations.
Stopping power ratio calculations are critical to accurate radiation dose calculation in treatment planning. Incorrect SPR calculations could result in planned radiation doses that differ from intended doses.
The affected software has been distributed worldwide, with confirmed U.S. distribution in West Virginia and additional distribution to the United Kingdom and Macao. The recall affects 149 serial numbers.
Healthcare facilities and radiation oncology departments using the affected software should contact Philips Medical Systems (Cleveland) Inc. for guidance on correcting the issue and verifying the accuracy of recent treatment plans generated with this software version.
The recalled product
- Product
- Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- dose-calculation-error
- treatment-planning-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Software Version Number: 18.0.5/UDI: (01)00884838103566
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- HighGE CARESCAPE Telemetry Server may lose patient ECG and oxygen saturation monitoring
FDA (Devices) · 2026-06-03