Elekta recalls Leksell GammaPlan 11.1 software due to potential risk of irradiating the wrong patient location during radiation treatment planning. Affected units may require software updates to prevent errors.
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.
Elek:ta recalled its Leksell GammaPlan 11.1 software for radiation treatment planning due to a risk of irradiating the wrong patient location. This could happen if users don't update obsolete references before creating new ones, potentially causing serious harm during treatment.
The software has a bug that causes users to create new stereotactic references without first updating obsolete ones. If not detected, this error might lead to radiation being directed to the wrong patient location during treatment, risking serious injury.
Medical professionals using Elekta's Leksell GammaPlan 11.1 software for radiation treatment planning are most at risk. Patients receiving treatment with this software version could be affected if errors occur.
Check for the software version 11.1 labeled as 'Leksell GammaPlan' on your device. The lot code 07340048311236 (LGP 11.1) identifies affected units.
Ensure obsolete references are updated to pre-plan references before creating new stereotactic references.
The recall indicates a potential risk of irradiating the wrong patient location, but the software may not cause harm if users follow proper procedures to update references.
Check for the software version 11.1 labeled as 'Leksell GammaPlan' with lot code 07340048311236 (LGP 11.1).
Update obsolete references to pre-plan references before creating new stereotactic references to prevent errors.
We’ve drafted a message you can send Elekta to request your refund or repair — edit it as you like.
Subject: Recall Z-1339-2026 — Elekta Elekta Hello, I own a Elekta that is covered by recall Z-1339-2026 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.
