Elekta, Inc. Recalls Leksell GammaPlan Software Due to Potential Incorrect Patient Irradiation Risk

What Happened

Elekta, Inc. has initiated a voluntary Class II recall of its Leksell GammaPlan software. The recall was triggered by a software error that occurs when defining a new stereotactic reference. If a user fails to first change an already defined obsolete reference to a pre-plan reference, the system may generate a treatment plan that potentially irradiates the incorrect patient location. This risk exists if the error is not detected by medical staff during the planning process.

Which Products Are Affected

The recall affects the Leksell GammaPlan Radionuclide RT Treatment planning system, specifically software versions 11.3 and 11.4.

• Product Name: Leksell GammaPlan
• Recall Number: Z-1340-2026
• Lot Codes: 07340048311878 (Version 11.3) and 07340201502136 (Version 11.4)

The product was distributed worldwide. In the United States, distribution included nationwide coverage with specific records for 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. International distribution reached over 45 countries, including Canada, China, France, Germany, Japan, and the United Kingdom.

What You Should Do

Elekta, Inc. initiated the recall on December 12, 2025, via a notification letter to affected customers. Medical facilities and practitioners using Leksell GammaPlan versions 11.3 or 11.4 should be vigilant when defining stereotactic references. Users must ensure that any obsolete references are manually changed to pre-plan references as required by the software workflow to prevent targeting errors. For additional information or technical support, facilities can contact Elekta, Inc. at their Atlanta headquarters located at 400 Perimeter Center Ter NE Ste 50, Atlanta, GA 30346-1227.

Why This Matters

This software error poses a high safety risk because incorrect radiation targeting can lead to the irradiation of healthy tissue or unintended anatomical sites, which may cause serious medical complications or injury to the patient.

Source

Information provided by the FDA. Recall Event ID: 98212.