RaySearch Laboratories AB is recalling approximately 159 units of its RayStation and RayPlan radiation therapy treatment planning software across various versions from 10B to v2025. The software has a defect where it fails to properly update and invalidate calculated radiation doses when users modify specific treatment areas, such as boluses, fixations, or supports, that lack defined contours or have material overrides. This failure to update can lead to medical professionals relying on outdated or incorrect dose information during cancer treatment planning.
If the software does not correctly recalculate radiation doses after geometric changes are made, patients may receive radiation therapy that does not match their actual treatment plan. This poses a serious risk of delivering incorrect radiation doses, which could result in radiation-induced injury to healthy tissue or ineffective treatment of the target area.
Recall #: Z-1102-2026. Expiration Date: 2027-02-01.
Recall #: Z-1103-2026. Expiration Date: 2027-06-22.
Recall #: Z-1104-2026. Expiration Date: 2028-03-20.
Recall #: Z-1105-2026. Expiration Date: 2028-07-07.
Recall #: Z-1106-2026. Expiration Date: 2030-02-21.
Recall #: Z-1107-2026. Expiration Date: 2027-02-01.
Recall #: Z-1108-2026. Expiration Date: 2030-04-15.
Recall #: Z-1109-2026. Expiration Date: 2029-06-28.
Recall #: Z-1110-2026. Expiration Date: 2030-10-22.
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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