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 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.
The software error arises when users do not update an obsolete reference before defining a new stereotactic reference. This oversight could lead to treatment plans that incorrectly target patient locations.
No specific injuries or incidents have been reported to date. The potential for harm remains high if the error occurs undetected.
Immediately stop using the Leksell GammaPlan software. Follow recall instructions from Elekta, Inc. or your healthcare provider.
For further assistance, contact Elekta, Inc. through their official website or customer service hotline.
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