Elekta recalled the Leksell GammaPlan Radionuclide RT Treatment Planning System on December 12, 2025. The software, used for treatment planning, may incorrectly irradiate patient locations due to a stereotactic reference error. This recall affects users worldwide, including in the U.S. and various international locations.
Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This may result in a treatment plan that potentially irradiates the incorrect patient location if the error is not detected by users.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Elekta, Inc. or your healthcare provider for instructions. Notification method: Letter
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The Leksell GammaPlan is a specialized software system used for planning treatments with the Gamma Knife, a device for delivering targeted radiation therapy. Healthcare providers purchase this software to enhance the precision and effectiveness of radiation treatments for patients with various conditions.
The hazard stems from an error in the software that allows users to inadvertently use an obsolete reference for treatment planning. If this happens, the software can generate a treatment plan that targets the wrong location on a patient, which could lead to severe health consequences.
This recall is not part of a broader industry pattern.
The recall creates an urgent need for healthcare providers to stop using the affected version of the software, impacting treatment continuity. Patients may experience delays in their treatment planning until a safe version of the software is implemented.
You can find the software version and Lot Code in the software's settings or about menu.
Expect a refund or replacement processing timeline of 4-8 weeks after the recall instructions are followed.
Keep records of your purchase, any communications regarding the recall, and your treatment plans.
The recall involves the Leksell GammaPlan Radionuclide RT Treatment Planning System, Software Version 11.1. The device is used for Leksell Gamma Knife treatment planning. The software is distributed worldwide including all U.S. states.
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