Elekta Leksell GammaPlan software recalled for treatment planning error risk
Elekta's Leksell GammaPlan treatment planning software (versions 11.3 and 11.4) has a software error that could cause incorrect treatment location data if users do not properly update reference settings. This could result in radiation therapy being directed to the wrong location if the error goes undetected.
From the FDA notice · Read the official notice ↗ · All Elekta recalls
What to do
- If you operate or manage a Gamma Knife facility, contact Elekta immediately about this issue
- Review recent treatment plans created with versions 11.3 or 11.4 to ensure correct patient locations were targeted
- Install any software update or patch from Elekta when available
- Ensure staff verify that obsolete reference settings are properly changed before creating new treatment plans
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: 11,3, 11.4 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-1340-2026
In the FDA's words
- Description
- 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. 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: 07340048311878 (LGP 11.3) 07340201502136 (LGP 11.4) 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…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¿… (this page)Z-1340-2026 · N/A