Pinnacle Radiation Therapy Planning System software ROI calculation error recall
Pinnacle Radiation Therapy Planning System software contains a defect causing potential Region of Interest calculation errors in specific patient positioning modes. Philips is recalling 810 affected units for software correction.
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: FDA Class II medical device with a confirmed software defect affecting treatment planning accuracy. No illnesses or injuries have been reported. The recall addresses a risk-of-harm scenario where radiation therapy planning could be compromised, fitting the rubric criterion for high-severity recalls with unconfirmed potential injuries.
Plain-English summary
The Pinnacle Radiation Therapy Planning System, manufactured by Philips Medical Systems (Cleveland) Inc, is being recalled due to a software defect that may cause inaccurate Region of Interest (ROI) calculations during expansion or contraction operations.
The defect affects patients positioned in three specific orientations: Head First Prone (HFP), Feet First Supine (FFS), and Feet First Prone (FFP). Incorrect ROI calculations could result in inaccurate radiation therapy treatment planning. Affected product versions include Multimodality Simulation Workspace 18.0.5 (Model 870258), TumorLOC 16.2 (Model 870226), TumorLOC 16.2.1 (Model 870227), TumorLOC 16.0.2 (Model 870218), and TumorLOC 14.0 (Model 870200).
Approximately 810 units have been distributed, with 350 in the United States across 43 states, Puerto Rico, and other territories. Healthcare facilities should contact Philips Medical Systems (Cleveland) Inc immediately for instructions on obtaining the software correction. Users should verify their system version and model number against the recalled versions listed.
The recalled product
- Product
- Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code: (01)00884838103566(10)18.0.5.22236 Pinnacle TumorLOC 16.2 Model 870226 UDI code: (01)00884838091122(10)16.2.0.60010 Pinnacle TumorLOC 16.2.1 Model 870227 UDI c
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- software-defect
- image-error
- therapy-planning-error
Distribution
Distributed nationwide across the United States.
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