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FDA-Device2026-02-18Class IIPROCESSING DEFECT

Elekta Leksell GammaPlan software recalled for treatment planning error risk

Elekta
OTHERNationwide distribution

Contact Elekta about Leksell GammaPlan software update

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.

  • 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
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: 11,3, 11.4 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-1340-2026

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