Elekta recalls Leksell GammaPlan 11.1 software due to systematic margin overestimation in certain treatment areas. Users should contact Elekta for updates.
The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of the volume.
Elekta is recalling its Leksell GammaPlan 11.1 software for radiation treatment planning because it overestimates the margin in specific areas. This could lead to inaccurate treatment targeting, potentially affecting patient safety.
The software overestimates the margin in certain areas of the treatment volume, which could lead to inaccurate radiation targeting. This might cause the radiation to affect more tissue than intended, potentially impacting treatment effectiveness and patient safety.
Patients and medical professionals using Elekta's Leksell GammaPlan 11.1 software for radiation treatment planning are affected. Those with the software version 11.1 are most at risk.
Check if you have the Leksell GammaPlan software version 11.1 for Elekta's Leksell Gamma Knife treatment planning systems. The software was sold with the Leksell Gamma Knife system.
Reach out to Elekta directly to confirm if your software version is affected and get guidance on next steps.
The software overestimates margin in certain areas, which could lead to inaccurate treatment targeting, but Elekta has not specified immediate risks.
Check if you have Leksell GammaPlan software version 11.1 for Elekta's Leksell Gamma Knife treatment planning systems.
Contact Elekta directly to confirm if your software version is affected and get guidance on next steps.
We’ve drafted a message you can send Elekta to request your refund or repair — edit it as you like.
Subject: Recall Z-1412-2019 — Elekta Elekta Hello, I own a Elekta that is covered by recall Z-1412-2019 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.
