Elekta Leksell GammaPlan 11.1 software recalled for radiation treatment planning error
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.
From the FDA notice · Read the official notice ↗ · All Elekta recalls
What to do
- 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
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 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.
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
This recall covers 2 products — see all of them.
Details
- Units affected
- N/A
- Illnesses reported
- None reported
- Manufactured in
- 400 Perimeter Center Ter NE Ste 50, N/A, Atlanta, GA, United States
- Classification
- Class II
- Recall number
- Z-1339-2026
In the FDA's words
- Description
- 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. 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. Lot Code: 07340048311236 (LGP 11.1) 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. Affected quantity: N/A
- 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.
2 products in this recall
The agency lists each product separately. Check every one you might have.
- Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11.1 Product Description: Leksell GammaPlan¿ is a… (this page)Z-1339-2026 · N/A
- Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11,3, 11.4 Product Description: Leksell GammaPlan¿…Z-1340-2026 · N/A