FDA-Device2026-02-18Class IIPROCESSING DEFECT

Elekta Leksell GammaPlan software recalled for treatment planning error risk

OTHERNationwide distributionMedical devices

What this means

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

The agency's original wording

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.

Intended for

Adults

Illnesses reported

None reported

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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