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High risk Medical DevicesClass II

Leksell GammaPlan Software Versions Recall

Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11,3, 11.4 Product Description: Leks

Updated December 12, 2025

Leksell GammaPlan software versions 11.3 and 11.4 contain a planning error that could cause radiation treatment to be directed at the wrong location if not caught by clinical staff. This radiosurgery planning tool is used with Gamma Knife systems.

Is the Elekta, Inc. recalled? Yes. This product was recalled by FDA on December 12, 2025. Details below.

What is recalled

Leksell GammaPlan Radionuclide RT treatment planning system software versions 11.3 and 11.4, made by Elekta, Inc.

Am I affected

You are affected if your facility uses Leksell GammaPlan software version 11.3 or 11.4 for Gamma Knife radiosurgery treatment planning.

What to do right now

Contact Elekta, Inc. immediately to report use of versions 11.3 or 11.4 and obtain a corrected software update. Do not proceed with treatment planning on affected software versions until the error has been corrected.

The hazard

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.

Brands affected

Elekta, Inc.
Source
FDA
Category
Medical Devices
Recall ID
fda-Z-1340-2026
Classification
Class II
Recalled
December 12, 2025
Read the official notice

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