Hitachi, Ltd. is recalling two units of its Proton Beam Therapy Systems (PROBEAT-FR and PROBEAT-CR) due to a software error in the patient positioning system. This anomaly can cause the patient to be positioned incorrectly during radiation treatment, leading to a discrepancy between the intended and actual treatment location. The recall affects two units distributed in Texas and Washington DC.
The software defect can cause the positioning system to place patients incorrectly, which may result in radiation being delivered to the wrong area or missing the intended target entirely.
Quantity: 1
Quantity: 1 unit
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Sources: FDA iRES · Raw API Response
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