Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning Recalled by Elekta, Inc. Due to Due to an error when defining a new...

Date: December 12, 2025
Company: Elekta, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Elekta, Inc. directly.

Affected Products

Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11.1 Product Description: Leksell GammaPlan¿ is a computer-based system designed for Leksell Gamma Knife¿ treatment planning.

Quantity: N/A

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Elekta, Inc.

Elekta, Inc. has 100 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report