Elekta, Inc. Recalls Leksell GammaPlan Software Over Radiation Targeting Error

What Happened

Elekta, Inc. has initiated a voluntary recall of its Leksell GammaPlan software following the discovery of a critical error in the system’s stereotactic reference definition process. The issue occurs when users define a new stereotactic reference without first changing an existing, obsolete reference to a pre-plan reference. This sequence can lead to the generation of a treatment plan that potentially irradiates the incorrect location on a patient if the error is not identified by the medical staff.

Which Products Are Affected

The recall specifically impacts the following medical device software:

• Brand Name: Leksell GammaPlan
• Product Name: Radionuclide RT Treatment planning system
• Software Version: 11.1
• Lot Code: 07340048311236
• Recall Number: Z-1339-2026

This software is a computer-based system used for Leksell Gamma Knife treatment planning. The affected units were distributed worldwide, including nationwide across the United States (specifically in AK, AZ, CA, CO, ST, FL, GA, HI, IA, IL, LA, MA, MI, MN, MO, NC, NJ, NM, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, and WV) and over 45 other countries.

What You Should Do

Elekta, Inc. notified affected customers via a formal letter initiated on December 12, 2025. Healthcare facilities using Leksell GammaPlan version 11.1 should ensure all users are aware of the specific error regarding stereotactic reference definitions. Users must follow the manufacturer’s guidance to ensure obsolete references are correctly updated to pre-plan references to avoid targeting errors. For additional information or technical support, facilities can contact Elekta, Inc. at their Atlanta, Georgia headquarters located at 400 Perimeter Center Ter NE Ste 50.

Why This Matters

This recall is classified as Class II by the FDA, signifying a situation where use of the product may cause temporary or medically reversible adverse health consequences. In this specific case, the failure to detect the software error could lead to radiation being applied to healthy tissue or the wrong surgical site, posing a significant risk to patient safety during Gamma Knife procedures.

Source

FDA Recall Notification - Recall Event ID 98212