Philips Medical Systems (Cleveland) Inc has recalled 810 units of its Pinnacle Radiation Therapy Planning System software due to a critical software defect. The recall includes 350 units in the United States and 460 units internationally, affecting Multimodality Simulation Workspace and various versions of Pinnacle TumorLOC. The software error can cause the "Region of Interest" (ROI) for a patient to display incorrectly when clinicians are expanding or contracting it during treatment planning, specifically when patients are positioned in Head First Prone, Feet First Supine, or Feet First Prone orientations.
This software error could lead to inaccurate radiation therapy planning. If a clinician relies on an incorrect image display to plan treatment, it could result in the patient receiving an incorrect dose of radiation or radiation being delivered to the wrong area of the body.
Recall #: Z-2570-2025
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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