Elekta recalls Monaco RTP System software builds 5.40.00-5.51.10 due to potential dose calculation errors if couch is removed and added during plan loading. Affected users should contact Elekta for details.
If a couch is removed while a plan is loaded, and then added back to the Studyset when the plan is unloaded, it is possible to calculate dose with the couch unassigned to the beams.
Elekta is recalling specific software versions of its Monaco RTP System because improper couch handling during treatment planning could lead to incorrect radiation dose calculations. This risk affects medical professionals using the system for radiation therapy.
If a treatment couch is removed while a radiation plan is loaded and then added back when the plan is unloaded, the system may calculate radiation doses incorrectly. This could lead to improper radiation delivery during treatment.
Medical professionals using Elekta's Monaco RTP System for radiation therapy treatment planning. Those with the specific software builds listed are most at risk.
Check if your Monaco RTP System has software builds 5.40.00, 5.40.01, 5.40.02, or 5.51.10. The unique device identifier (UDI) codes listed in the recall notice also help identify affected units.
Verify your Monaco RTP System software version matches the recalled builds (5.40.00, 5.40.01, 5.40.02, or 5.51.10).
Software builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10.
Check your software version against the recalled builds listed in the notice. The unique device identifier (UDI) codes provided also help identify affected units.
The recall notice does not specify a remedy. Contact Elekta directly for further instructions.
We’ve drafted a message you can send Elekta to request your refund or repair — edit it as you like.
Subject: Recall Z-2406-2021 — Elekta Elekta Hello, I own a Elekta that is covered by recall Z-2406-2021 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.
