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Medium risk Electronics & LightingClass II

Elekta, Inc. 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

Elekta, Inc. is recalling Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11,3, 11.4 Product Description: Leks. 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.

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

What is recalled

Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11,3, 11.4 Product Description: Leksell GammaPlan¿ is a computer-based system designed for Leksell Gamma Knife¿ treatment planning.

Am I affected

You may be affected if you own this product. Check the brand, model, and lot/date codes listed in the recall against your item.

What to do right now

Voluntary: Firm initiated

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
Electronics & Lighting
Recall ID
fda-Z-1340-2026
Classification
Class II
Recalled
December 12, 2025
Read the official notice

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