Elekta, Inc. Recalls Leksell GammaPlan Software Over Radiation Targeting Error
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Elekta, Inc. has issued a voluntary recall for Leksell GammaPlan version 11.1 due to a software error that could result in radiation treatment being delivered to the incorrect patient location.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on February 25, 2026 and geographically references Worldwide. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
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What Happened
Elekta, Inc. has initiated a voluntary recall of its Leksell GammaPlan software following the discovery of a critical error in the system's stereotactic reference definition process. The issue occurs when users define a new stereotactic reference without first changing an existing, obsolete reference to a pre-plan reference. This sequence can lead to the generation of a treatment plan that potentially irradiates the incorrect location on a patient if the error is not identified by the medical staff.
Which Products Are Affected
The recall specifically impacts the following medical device software:
- Brand Name: Leksell GammaPlan
- Product Name: Radionuclide RT Treatment planning system
- Software Version: 11.1
- Lot Code: 07340048311236
- Recall Number: Z-1339-2026
This software is a computer-based system used for Leksell Gamma Knife treatment planning. The affected units were distributed worldwide, including nationwide across the United States (specifically in 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) and over 45 other countries.
What You Should Do
Elekta, Inc. notified affected customers via a formal letter initiated on December 12, 2025. Healthcare facilities using Leksell GammaPlan version 11.1 should ensure all users are aware of the specific error regarding stereotactic reference definitions. Users must follow the manufacturer's guidance to ensure obsolete references are correctly updated to pre-plan references to avoid targeting errors. For additional information or technical support, facilities can contact Elekta, Inc. at their Atlanta, Georgia headquarters located at 400 Perimeter Center Ter NE Ste 50.
Why This Matters
This recall is classified as Class II by the FDA, signifying a situation where use of the product may cause temporary or medically reversible adverse health consequences. In this specific case, the failure to detect the software error could lead to radiation being applied to healthy tissue or the wrong surgical site, posing a significant risk to patient safety during Gamma Knife procedures.
Source
Original source: FDA Official Notice ↗
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