Elekta, Inc. is recalling Leksell GammaPlan treatment planning software versions 11.1, 11.3, and 11.4 due to a software error that occurs when defining new stereotactic references. If users do not first change an obsolete reference to a pre-plan reference, the software may generate a treatment plan that targets the wrong location in the patient's body. Consumers and healthcare facilities using this system for Gamma Knife treatments should contact the manufacturer for guidance on detecting and preventing this error.
The software error can cause the system to irradiate the incorrect patient location if the user fails to manually update obsolete references. This could lead to serious medical complications or ineffective treatment if the planning error is not detected by clinical staff prior to the procedure.
Recall #: Z-1339-2026; Computer-based system designed for Leksell Gamma Knife treatment planning.
Recall #: Z-1340-2026; Computer-based system designed for Leksell Gamma Knife treatment planning.
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.