Philips Medical Systems recalled 810 units of its Radiation Therapy Planning System on August 5, 2025. A software issue may cause image errors during treatment planning. Affected models include Pinnacle TumorLOC and Multimodality Simulation Workspace.
Due to a software issue, there is a potential image error of the Region of Interest for expansion/contraction for HFP (Head First Prone), FFS (Feet First Supine) and FFP (Feet First Prone) orientations.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Philips Medical Systems (Cleveland) Inc or your healthcare provider for instructions. Notification method: Letter
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The recall affects the Pinnacle Radiation Therapy Planning System, including models 870258, 870226, 870227, 870218, and 870200. These devices were distributed nationwide in the U.S. and internationally. Prices for these systems vary based on the model.
Due to a software issue, there is a potential image error of the Region of Interest for expansion and contraction for specific patient orientations. This could lead to improper treatment planning.
Stop using the affected devices immediately. Follow the recall instructions provided by Philips Medical Systems and contact your healthcare provider for further guidance.
For more information, contact Philips Medical Systems at 1-800-XXX-XXXX or visit their website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-2570-2025.
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