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Use caution Medical device recall · FDA · Published December 12, 2025

Elekta Leksell GammaPlan software version 11.3/11.4 recall: Risk of incorrect patient

Elekta recalls Leksell GammaPlan radionuclide RT treatment planning software versions 11.3 and 11.4 due to potential risk of irradiating the wrong patient location during treatment planning.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1340-2026Medical deviceElekta ›
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Contact the company

Recalling firmElekta, Inc.400 Perimeter Center Ter NE Ste 50 · Atlanta, GA 30346-1227
✎ GovInfoNow plain-language explainer

Elekta is recalling specific versions of its Leksell GammaPlan software for radiation treatment planning. The software could incorrectly target a patient's location if users don't update an outdated reference before creating a new one, which might lead to unintended radiation exposure. Read more at govinfonow.com/recall/50462-elekta-leksell-gammaplan-software-version-11-3-11-4-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/50462-elekta-leksell-gammaplan-software-version-11-3-11-4-recall · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1340-2026

Cite this page

“Elekta Leksell GammaPlan software version 11.3/11.4 recall: Risk of incorrect patient.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/50462-elekta-leksell-gammaplan-software-version-11-3-11-4-recall. Based on FDA recall #Z-1340-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1340-2026%22&limit=1).

The FDA announced on Dec. 12, 2025, that Elekta, Inc. is recalling the Leksell GammaPlan Radionuclide RT Treatment planning system software versions 11.3 and 11.4 due to a hazard that may result in incorrect patient irradiation.

How to tell if you have it

  • Brand: Elekta
  • Product Name: Leksell GammaPlan Radionuclide RT Treatment planning system
  • Software Version: 11.3, 11.4
  • Lot Code: 07340048311878 (LGP 11.3) 07340201502136 (LGP 11.4)

The hazard

According to the FDA, an error when defining a new stereotactic reference may cause users to fail to 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.

Context

GovInfoNow's records show Elekta, Inc. has 39 other recalls on record since June 19, 2017. Other recent recalls of similar products include Elekta MOSAIQ Oncology System Software Recall (May 21, 2026), Elekta Fletcher CT/MR Shielded Applicator Set Recall (April 3, 2026), and Elekta Leksell Vantage Arc System Recall (March 19, 2026). Other recent recalls of similar products include RayStation/RayPlan 10B Software Recall (Nov. 28, 2025), RayStation/RayPlan Software 11A Recalls (Nov. 28, 2025), and RayStation/RayPlan Software Recall (Nov. 28, 2025).

How to tell if you have this one

Check if you have Elekta's Leksell GammaPlan software versions 11.3 (lot code 07340048311878) or 11.4 (lot code 07340201502136).

  • Brand
    Elekta
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • 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.
Recall numberProduct, codes & lots
Z-1339-2026Brand 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.; Lot Code: 07340048311236 (LGP 11.1)
Z-1340-2026Brand 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.; Lot Code: 07340048311878 (LGP 11.3) 07340201502136 (LGP 11.4)
Based on the official FDA remedy

What to do — step by step

  1. Check Software Version

    Verify your software version by checking the product description or lot code on the software packaging.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 31 states.

Alaska: named in the noticeAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: nationwideINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: nationwideKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: nationwideMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: nationwideKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFLPuerto Rico: named in the noticePR

FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alaska, Arizona, California, Colorado, Florida, Georgia, Hawaii, Illinois, Iowa, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Dec 12, 202512. FDA classified it Class II: Feb 10, 202623. Published in FDA’s Enforcement Report: Feb 18, 2026320252026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1340-2026 (December 12, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1340-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA