Ion Beam Applications S.A. is recalling 4 units of the IBA Proton Therapy System - PROTEUS 235 because a safety interface is disabled in the system's configuration. This defect prevents the Therapy Safety System from automatically stopping the radiation beam if the signal from an external gating device is lost. One affected unit was distributed in Florida, and three others were sent to Japan and Italy. Users should contact the manufacturer immediately to resolve this safety configuration issue.
The system may fail to interrupt beam delivery if a safety signal is lost, leading to a risk of radiation mistreatment or incorrect dosage during patient therapy.
Quantity: 4 units (1 US in Florida, 3 Outside US in Japan and Italy).
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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