Elekta recalls Monaco RTP System software versions 5.11.00-5.11.03 due to potential inaccurate radiation dose calculations in treatment plans. Affected users should contact Elekta for details.
Re-optimization, after adding contours without forced density outside the external structure, may result in inaccurate dose presentation.
Elekta is recalling its Monaco RTP System software versions 5.11.00 through 5.11.03 because these versions may produce inaccurate radiation dose calculations for treatment plans. This could lead to incorrect radiation delivery to patients during cancer therapy.
The software may calculate radiation doses incorrectly when re-optimizing treatment plans after adding contours without forced density outside the external structure. This could result in improper radiation delivery to patients during cancer treatment.
Healthcare professionals using the Monaco RTP System for radiation treatment planning are affected. Patients receiving radiation therapy using these software versions may be at risk.
Check if you have the Monaco RTP System software versions 5.11.00, 5.11.01, 5.11.02, or 5.11.03. The UDI numbers include (01)00858164002169(10) followed by the software version.
Reach out to Elekta for specific instructions on how to verify your software version and get the correct remedy.
Software versions 5.11.00, 5.11.01, 5.11.02, and 5.11.03 are affected.
Check your software version in the Monaco RTP System settings; affected versions are 5.11.00 through 5.11.03.
Contact Elekta directly for instructions on verifying your software and getting the correct remedy.
We’ve drafted a message you can send Elekta to request your refund or repair — edit it as you like.
Subject: Recall Z-1233-2023 — Elekta Elekta Hello, I own a Elekta that is covered by recall Z-1233-2023 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.
