Elekta recalled the Leksell GammaPlan RT Treatment Planning System on December 12, 2025, due to a software error. This defect may lead to incorrect patient irradiation if not detected. Healthcare providers must stop using the software immediately.
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 system is a computer-based software designed for treatment planning of patients undergoing Leksell Gamma Knife therapy. Healthcare professionals utilize this software to create accurate treatment plans for radiation therapy.
The software's failure to update obsolete references can lead to incorrect treatment plans that may result in irradiating the wrong patient area, posing a serious risk to patient safety.
This recall is not part of a broader industry pattern.
The recall affects patient treatment planning, which is critical in delivering effective radiation therapy. It may cause delays in patient care while alternative solutions are sought.
Lot codes and software version information can typically be found in the software's settings or installation details.
Expect a response within 4-6 weeks for refunds or replacements following the recall process.
Keep copies of any receipts, correspondence with Elekta, and records of the software version being used.
The recall affects Leksell GammaPlan RT Treatment Planning Software versions 11.3 and 11.4. The affected lot codes include 07340048311878 (LGP 11.3) and 07340201502136 (LGP 11.4). This software was distributed globally, including across all U.S. states.
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