Hitachi America, Ltd. has recalled three PROBEAT proton beam irradiation systems (models PROBEAT-FR, PROBEAT-CR, and PROBEAT-V) due to a software defect in the patient positioning system. When clinicians use the 3D to 3D matching mode to transfer images, clicking the "Float Image Selection" button may result in an insufficient number of images being displayed. This technical failure can interfere with the system's ability to accurately align the therapeutic proton beam with the patient's treatment site. Hitachi has notified affected facilities in Tennessee, Texas, and Washington via letter to initiate corrective actions.
The software error may prevent medical staff from viewing all necessary images required for precise patient positioning. This could lead to inaccuracies in delivering the prescribed radiation dose to the target treatment area, potentially impacting the effectiveness of the cancer therapy or affecting surrounding healthy tissue.
Firm initiated correction via notification letter.
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.
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Sources: FDA iRES · Raw API Response
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