Elekta recalls Monaco RTP software versions 5.10 and 5.11 due to potential incorrect monitor unit scaling during radiation treatment planning. Affected units may require software update to prevent treatment errors.
When creating 3D plans using either MU or Dose weighting modes, if the user changes the number of fractions, rescales the plan and then changes the wedge angle, the Monitor Units are scaled incorrectly.
Elekta is recalling its Monaco RTP software versions 5.10 and 5.11 for radiation treatment planning systems. This recall occurs because changing treatment parameters can cause incorrect monitor unit calculations, potentially leading to unsafe radiation doses.
When creating 3D treatment plans using specific modes, changing the number of radiation fractions, rescaling the plan, and then adjusting the wedge angle can cause the software to calculate incorrect monitor units. This error may lead to improper radiation doses being delivered to patients.
Radiation therapy professionals using Elekta Monaco RTP systems with software versions 5.10 or 5.11 are most at risk. Patients receiving treatments with these systems could be affected if the software error occurs.
Check if your Monaco RTP system has software version 5.10 or 5.11. The recall applies to all units installed with these software versions.
Install the corrected software version from Elekta to fix the scaling issue.
The recall applies to Monaco RTP systems with software versions 5.10 or 5.11. If you use these versions, you may need to update the software to avoid incorrect monitor unit calculations.
Check your Monaco RTP system's software version. Versions 5.10 and 5.11 are affected by this recall.
No. The recall requires updating the software to fix the issue, but you can continue using the system after the update.
We’ve drafted a message you can send Elekta to request your refund or repair — edit it as you like.
Subject: Recall Z-2091-2019 — Elekta Elekta Hello, I own a Elekta that is covered by recall Z-2091-2019 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.
