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.

Recall Insight

This FDA Devices action (record #Z-1340-2026) was formally reported on February 18, 2026, with the manufacturer initiating the action on December 12, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Elekta, Inc. is listed as the recalling firm, operating out of Atlanta, GA. Federal records indicate N/A units are affected.

The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: Worldwide - U.S. Nationwide distribution including in the states of 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. The countries o…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. Because this recall is recent, remedy windows and replacement inventory are most likely still actively available from the firm or retailer. Always cross-check the recall number against the official agency page before relying on any summary.