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FDA-Device2026-02-18Class IIPROCESSING DEFECT

Elekta Leksell GammaPlan 11.1 software recalled for radiation treatment planning error

Elekta
OTHERNationwide distribution

Check Elekta Leksell GammaPlan treatment plans

Elekta's Leksell GammaPlan software version 11.1 has a bug that can cause incorrect radiation targeting during Gamma Knife treatment planning. If users don't update an old reference point before creating a new treatment plan, the radiation may be aimed at the wrong location. This error may not be caught during normal review.

  • Verify your treatment facility uses Leksell GammaPlan 11.1
  • Review any treatment plans created with this software version
  • Before creating new plans, ensure all obsolete stereotactic references are changed to pre-plan references
  • Contact Elekta for software guidance or an updated version
Hazard

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.

Sold states
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.
Affected count
N/A
Manufactured in
400 Perimeter Center Ter NE Ste 50, N/A, Atlanta, GA, United States
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1339-2026

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