Elekta recalls Monaco radiation treatment software versions 5.40.00-5.40.02 and 5.51.10 due to potential unintended contour changes saving image sets, which could affect radiation treatment plans.
Contour changes can be saved on an unintended image set. In addition, these contour edits do not cause the dose to be frozen on the plans associated with that image set.
Elekta is recalling its Monaco radiation treatment planning software versions 5.40.00 through 5.40.02 and 5.51.10. These versions may save contour changes to unintended image sets, which could lead to incorrect radiation treatment plans being generated.
The software may save contour changes to unintended image sets, meaning treatment plans could be altered without the user realizing it. These changes do not freeze the dose, so the software might still generate incorrect treatment plans after edits.
Healthcare providers using Elekta Monaco software for radiation treatment planning are affected. Patients receiving radiation therapy through this software may be at risk if the software errors cause incorrect treatment plans.
Check for software versions 5.40.00, 5.40.01, 5.40.02, or 5.51.10 in the Elekta Monaco system. The software is used for creating radiation treatment plans for patients with prescriptions for external beam radiation therapy.
Install the latest software version from Elekta to fix the contour saving issue.
The recall does not indicate a risk of serious injury to patients. The issue affects treatment planning software but does not cause immediate harm.
Check the software version in your Elekta Monaco system; affected versions are 5.40.00 through 5.40.02 and 5.51.10.
No, the recall does not require immediate discontinuation. Users should update to the latest version to resolve the issue.
We’ve drafted a message you can send Elekta to request your refund or repair — edit it as you like.
Subject: Recall Z-2563-2021 — Elekta Elekta Hello, I own a Elekta that is covered by recall Z-2563-2021 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.
