Ion Beam Applications S.A. is recalling 2 units of the IBA Proton Therapy System - PROTEUS 235 (PTS-11 and PTS-12 versions with C230 accelerator) because the system may fail to stop irradiation even when critical control parameters are outside of safe tolerances. This defect means the accelerator control unit might not interrupt the proton beam as designed during patient treatment. These units were distributed in the state of Virginia and in India.
The failure of the control unit to interrupt irradiation when parameters are out of tolerance could lead to patients receiving unintended or excessive radiation doses during cancer treatment. While no specific injuries were reported in this notification, radiation delivery errors can cause serious tissue damage or ineffective treatment of tumors.
Manufacturer initiated technical correction
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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