Xcision Medical Systems is recalling 4 units of the GammaPod Treatment Planning System, a component used in radiation therapy for breast cancer. The system’s software allowed users to import patient treatment structures (RTSS) from a previous CT scan instead of the current one, which can lead to radiation being delivered to the wrong area of the breast. This defect affects specific units distributed in Maryland, Pennsylvania, Texas, and Italy. Because this is a specialized medical device used in clinical settings, patients who have undergone treatment with the GammaPod system should consult their medical team to ensure their treatment plan was accurate.
If an old CT scan's mapping is used for a new radiation treatment, the radiation dose may be delivered to healthy tissue while missing the intended tumor or treatment site. This could result in ineffective cancer treatment or radiation injury to non-targeted areas of the breast.
manufacturer or healthcare provider consultation
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.
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Sources: FDA iRES · Raw API Response
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