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.
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.
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 The software could incorrectly target a patient's location if users don't update an outdated reference before creating a new one, which might lead to unintended radiation exposure.
The software has an error that causes users to potentially create a treatment plan targeting the wrong patient location if they don't first update an outdated reference to a pre-plan reference. This could lead to unintended radiation exposure during treatment.
Healthcare professionals using Elekta's Leksell GammaPlan software for radiation treatment planning. Those who have the specific software versions 11.3 or 11.4 are most at risk.
Check if you have Elekta's Leksell GammaPlan software versions 11.3 (lot code 07340048311878) or 11.4 (lot code 07340201502136).
Verify your software version by checking the product description or lot code on the software packaging.
The software may create a treatment plan that irradiates the incorrect patient location if users don't update an outdated reference to a pre-plan reference before creating a new one.
Software versions 11.3 (lot code 07340048311878) and 11.4 (lot code 07340201502136).
No, but you should check your software version and update references before creating new treatment plans to avoid potential errors.
We’ve drafted a message you can send Elekta to request your refund or repair — edit it as you like.
Subject: Recall Z-1340-2026 — Elekta Elekta Hello, I own a Elekta that is covered by recall Z-1340-2026 from Elekta. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
