Elekta recalls Monaco RTP System software versions 5.50 and 5.51 due to potential incorrect radiation dose calculations, which could affect cancer treatment safety. Affected users should contact Elekta for details.
It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.
Elekta is recalling two software versions of its Monaco radiation treatment planning system because changes to electron density settings might cause incorrect dose calculations. This could lead to unsafe radiation treatment plans for cancer patients.
The system may unintentionally change electron density settings during radiation treatment planning, leading to incorrect dose calculations. This could result in patients receiving unsafe radiation doses during cancer treatment.
Healthcare professionals using the Monaco RTP System software versions 5.50 and 5.51 for radiation treatment planning. Patients receiving cancer treatment with this system are at risk if the software produces incorrect dose calculations.
Check if you have the Monaco RTP System software versions 5.50 or 5.51. The system is used for radiation treatment planning in cancer care and has a unique identifier (UDI) starting with (01)00858164002244(10) for version 5.50.00.
Reach out to Elekta for specific guidance on the recalled software versions and next steps.
The recall is for potential incorrect dose calculations, which could affect cancer treatment safety. However, the hazard is not described as causing serious injury in normal use, so it's considered low risk.
Software versions 5.50 and 5.51 of the Monaco RTP System.
Check for the unique identifier (UDI) starting with (01)00858164002244(10) for version 5.50.00 or (01)00858164002268(10) for version 5.51.00.
We’ve drafted a message you can send Elek: The Monaco RTP System to request your refund or repair — edit it as you like.
Subject: Recall Z-2561-2019 — Elek: The Monaco RTP System Elek: The Monaco RTP System Hello, I own a Elek: The Monaco RTP System that is covered by recall Z-2561-2019 from Elek: The Monaco RTP System. 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.
