Elek: Monaco radiation treatment software version 5.40 may use incorrect dose optimization models during plan adaptation. Affected users should contact Elekta for details.
If Improve Target Dose was chosen as an optimization model in a previous treatment session, Monaco¿ will automatically use this optimization model again when proceeding with the online plan adaptation of a completion plan when it should not.
Elekta's Monaco radiation treatment planning software version 5.40 may incorrectly reuse a previous dose optimization model during plan adaptation. This could lead to improper radiation dosing in treatments.
The software may automatically reuse an optimization model from a previous treatment session when adapting a new treatment plan. This could cause incorrect radiation dosing if the model was not appropriate for the current patient.
Radiation therapy professionals using Elekta's Monaco software version 5.40 for treatment planning. Those with recent treatment sessions using the 'Improve Target Dose' optimization model are most at risk.
Check if you have Elekta's Monaco software version 5.40. Look for previous use of the 'Improve Target Dose' optimization model in treatment sessions.
Reach out to Elekta directly for specific guidance on whether your software version is affected and next steps.
The recall indicates a potential for incorrect dose calculations but does not specify serious injury risk. The hazard level is low risk.
Check if you have Elekta's Monaco software version 5.40 and if you previously used the 'Improve Target Dose' optimization model in treatment sessions.
Contact Elekta directly for specific guidance on whether your software version is affected and 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-0965-2019 — Elekta Elekta Hello, I own a Elekta that is covered by recall Z-0965-2019 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.
