Class IIReported 2026-02-18

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.

Reason for Recall

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.

Recall Number

Z-1339-2026

Classification

Class II

Status

Ongoing

Category

device

Initiated

2025-12-12

Reported

2026-02-18

Distribution

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 of Algeria, Argentina, Australia, Belarus, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, France, Georgia, Germany, Hong Kong, India, Iran, Iraq, Italy, Japan, Jordan, Republic of Korea, Kuwait, Libyan Arab Jamahiriya, Lithuania, Malaysia, Mexico, Morocco, Netherlands, Norway, Pakistan, Peru, Poland, Romania, Russian Federation, Saudi Arabia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, and Vietnam.

Code Info

Lot Code: 07340048311236 (LGP 11.1)

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.