FDA recall, , Moderate risk
Elekta Leksell GammaPlan Radionuclide RT Treatment Planning System
Leksell GammaPlan treatment planning software has an error that may cause incorrect patient location irradiation.
Summary by Recall Canary from the FDA notice
What happened
Elekta, Inc. of Atlanta, Georgia began a recall of Leksell GammaPlan Radionuclide RT Treatment planning system software versions 11.1 and 11,3, 11.4 on December 12, 2025. The FDA added the recall to its Enforcement Report and classified it on February 10, 2026.
The recall is 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, which may result in a treatment plan that potentially irradiates the incorrect patient location if the error is not detected by users.
The product is a computer-based system designed for Leksell Gamma Knife treatment planning, distributed worldwide including U.S. nationwide and in many countries.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI and lot code are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Leksell GammaPlan Radionuclide RT Treatment planning system
- UDI-DI
- 07340048311236
- Lot code
- 11.1
- Software version
- 11.1
- UDI-DI
- 07340048311878
- 07340201502136
- Lot code
- 11.3
- 11.4
- Software version
- 11,3, 11.4
Recall details
- Company began the recall
- Sold in
Worldwide - U.S. Nationwide distribution including in the states of Alaska, Arizona, California, Colorado, ST, Florida, Georgia, Hawaii, Iowa, Illinois, Louisiana, Massachusetts, Michigan, Minnesota. Missouri, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, PR, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, and West Virginia. 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.
- Company
- Elekta, Inc.Atlanta, Georgia
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98212
- Recall numbers
- Z-1339-2026 to Z-1340-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
