Ion Beam Applications S.A. is recalling 8 units of the IBA Proton Therapy System (PROTEUS 235, versions PTS-10, PTS-11, and PTS-12). The recall was issued because the system may fail to prevent irradiation even when critical safety parameters are outside of their allowed tolerance levels. This defect could lead to patients receiving radiation doses that do not match their prescribed treatment plans. These systems were distributed to medical facilities in Arkansas, Florida, Louisiana, Kansas, Michigan, Texas, and Virginia.
The system's failure to stop irradiation when safety parameters are out of tolerance can lead to 'mistreatment,' where a patient receives an incorrect or unintended dose of radiation, potentially causing serious health complications or injury.
Contact healthcare provider or manufacturer
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.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.