Elekta Monaco Radiation Planning System Recall: Incorrect Energy Optimization Risk
Elekta recalls Monaco radiation treatment planning software builds 5.40.00, 5.50.00, and 5.51.00 due to incorrect energy optimization during dose calculations. Affected users should contact Elekta for remediation.
Lower-risk recall
Monaco is using the incorrect energy when optimizing and calculating dose.
Contact the company
What happened, in plain English
Elekta is recalling specific versions of its Monaco radiation treatment planning software because they use the wrong energy levels when optimizing radiation doses. This could lead to inaccurate treatment planning, potentially affecting patient safety during radiation therapy. Read more at govinfonow.com/recall/66450-elekta-monaco-radiation-planning-system-recall-incorrect-energy-optimization-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/66450-elekta-monaco-radiation-planning-system-recall-incorrect-energy-optimization-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0670-2020
Cite this page
“Elekta Monaco Radiation Planning System Recall: Incorrect Energy Optimization Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66450-elekta-monaco-radiation-planning-system-recall-incorrect-energy-optimization-risk. Based on FDA recall #Z-0670-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0670-2020%22&limit=1).
Why it’s dangerous
The Monaco software uses incorrect energy levels when optimizing and calculating radiation doses. This could result in improper radiation treatment planning, potentially affecting the accuracy of radiation therapy for patients.
Who’s affected
Healthcare professionals using Elekta's Monaco radiation treatment planning software with the specified software builds are affected. Patients receiving radiation therapy using these versions may be at risk of inaccurate treatment planning.
How to tell if you have this one
Check if your Monaco software version is 5.40.00, 5.50.00, or 5.51.00. The UDI GTIN numbers are listed in the recall notice for identification.
- Brand
Elekta- Product
Elekta Inc recalls Monaco Radiation Treatment Planning System (RTP) System- Category
Medical device
What to do — step by step
Check Software Version
Identify your Monaco software version by checking the build number in the software interface.
Contact Elekta
Reach out to Elekta directly for guidance on remediation steps for affected software versions.
Where it went and when
Where it was distributed
Distributed in 6 states, and outside the U.S.
FDA distribution: “IA, IN, NY, OH, TX, WI. Internationally distributed to: Australia, Canada, China, Denmark, Germany, Greece, Hong Kong, Italy, Netherlands, Sweden, Switzerland, United Kingdom.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Indiana, Iowa, New York, Ohio, Texas, Wisconsin.
Recall timeline
FDA published this recall 26 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.
Questions people ask
What should I do if I have the affected software?
Contact Elekta directly for remediation steps as there is no immediate action required beyond verification.
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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-0670-2020 (November 22, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0670-2020 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.