RaySearch Laboratories AB is recalling 154 units of RayStation and RayPlan radiation therapy planning software because a user error can lead to selecting the wrong material for medical implants. Specifically, if 'Silicon (Si)' is accidentally selected for a silicone gel polymer implant, it can cause errors in radiation dose calculations. This recall affects multiple software versions including 8B through 12B, 2023B, and 2024A, which were distributed worldwide and across the United States.
Using the chemical element 'Silicon' instead of 'silicone' for a polymer implant results in incorrect density and material data being used for radiation treatment planning. This can lead to the patient receiving an incorrect dose of radiation during therapy, potentially causing injury or ineffective treatment.
Manufacturer Notification Letter and technical guidance.
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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