Elekta Monaco RTP Software 5.10/5.11: Incorrect Monitor Units Scaling Risk
Elekta recalls Monaco RTP software versions 5.10 and 5.11 due to potential incorrect monitor unit scaling during radiation treatment planning. Affected units may require software update to prevent treatment errors.
Use caution until it’s fixed
When creating 3D plans using either MU or Dose weighting modes, if the user changes the number of fractions, rescales the plan and then changes the wedge angle, the Monitor Units are scaled incorrectly.
Contact the company
What happened, in plain English
Elekta is recalling its Monaco RTP software versions 5.10 and 5.11 for radiation treatment planning systems. This recall occurs because changing treatment parameters can cause incorrect monitor unit calculations, potentially leading to unsafe radiation doses. Read more at govinfonow.com/recall/67503-elekta-monaco-rtp-software-5-10-5-11-incorrect-monitor.
Source Summary by GovInfoNow · govinfonow.com/recall/67503-elekta-monaco-rtp-software-5-10-5-11-incorrect-monitor · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2091-2019
Cite this page
“Elekta Monaco RTP Software 5.10/5.11: Incorrect Monitor Units Scaling Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67503-elekta-monaco-rtp-software-5-10-5-11-incorrect-monitor. Based on FDA recall #Z-2091-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2091-2019%22&limit=1).
Why it’s dangerous
When creating 3D treatment plans using specific modes, changing the number of radiation fractions, rescaling the plan, and then adjusting the wedge angle can cause the software to calculate incorrect monitor units. This error may lead to improper radiation doses being delivered to patients.
Who’s affected
Radiation therapy professionals using Elekta Monaco RTP systems with software versions 5.10 or 5.11 are most at risk. Patients receiving treatments with these systems could be affected if the software error occurs.
How to tell if you have this one
Check if your Monaco RTP system has software version 5.10 or 5.11. The recall applies to all units installed with these software versions.
- Brand
Elekta- Category
Medical device
What to do — step by step
Update Software
Install the corrected software version from Elekta to fix the scaling issue.
How this recall unfolded
Recall timeline
FDA published this recall 35 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-2091-2019 (July 3, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2091-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.