Ion Beam Applications S.A. is recalling 35 units of the IBA Proton Therapy System, specifically the PROTEUS 235 ProteusPLUS and ProteusONE models, across several software versions (PTS-8, 10, 11, and 12). The recall was initiated because the safety parameter verification mechanisms, which are designed to ensure the system operates within safe limits, can be deactivated during clinical use. This defect could lead to the delivery of incorrect radiation doses during patient treatment. Consumers and facilities using these systems should contact the manufacturer immediately for guidance on software updates or operational precautions.
If the safety verification mechanisms are deactivated during clinical runtime, the system may fail to detect or prevent unsafe treatment parameters. This poses a risk of delivering inaccurate radiation doses to patients, which could lead to serious medical complications or ineffective treatment.
Manufacturer safety verification and instruction
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
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