Elekta recalls Monaco RTP radiation treatment software version 5.40.00 and 5.40.01 due to potential inaccurate radiation dose delivery. Affected users should contact Elekta for details.
The Monaco RTP Radiation Treatment Planning System may change the shape and volume of the contour potentially resulting in the device delivering an inaccurate dose.
Elekta is recalling its Monaco RTP radiation treatment planning software versions 5.40.00 and 5.40.01 because it may deliver inaccurate radiation doses to patients. This could lead to improper treatment outcomes if the software changes the shape and volume of the treatment contour.
The Monaco RTP software may alter the shape and volume of the treatment contour, which could cause the radiation to be delivered in an inaccurate dose. This might result in improper treatment outcomes for patients receiving radiation therapy.
Healthcare providers using Elekta's Monaco RTP software for radiation treatment planning are affected. Patients receiving treatment with this software version may be at risk if the software delivers inaccurate radiation doses.
Check for software versions 5.40.00 or 5.40.01 in the Monaco RTP system. The software build numbers are listed in the product description.
Identify the software version by checking the build number in the Monaco RTP system.
The recall states the software may change the shape and volume of the treatment contour, potentially leading to inaccurate radiation doses. However, the specific risk level is not detailed in the official notice.
Check the software build number in the Monaco RTP system; versions 5.40.00 and 5.40.01 are affected.
The official recall notice does not specify a remedy or action steps beyond checking the software version.
We’ve drafted a message you can send Elekta to request your refund or repair — edit it as you like.
Subject: Recall Z-1825-2020 — Elekta Elekta Hello, I own a Elekta that is covered by recall Z-1825-2020 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.
