Elekta Monaco RTP System Recall: Inaccurate Radiation Treatment Plans
Elekta recalls Monaco RTP System software versions 5.11.00-5.11.03 due to potential inaccurate radiation dose calculations in treatment plans. Affected users should contact Elekta for details.
Recall notice
Re-optimization, after adding contours without forced density outside the external structure, may result in inaccurate dose presentation.
Contact the company
What happened, in plain English
Elekta is recalling its Monaco RTP System software versions 5.11.00 through 5.11.03 because these versions may produce inaccurate radiation dose calculations for treatment plans. This could lead to incorrect radiation delivery to patients during cancer therapy. Read more at govinfonow.com/recall/58839-elekta-monaco-rtp-system-recall-inaccurate-radiation-treatment-plans.
Source Summary by GovInfoNow · govinfonow.com/recall/58839-elekta-monaco-rtp-system-recall-inaccurate-radiation-treatment-plans · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1233-2023
Cite this page
“Elekta Monaco RTP System Recall: Inaccurate Radiation Treatment Plans.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58839-elekta-monaco-rtp-system-recall-inaccurate-radiation-treatment-plans. Based on FDA recall #Z-1233-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1233-2023%22&limit=1).
Why it’s dangerous
The software may calculate radiation doses incorrectly when re-optimizing treatment plans after adding contours without forced density outside the external structure. This could result in improper radiation delivery to patients during cancer treatment.
Who’s affected
Healthcare professionals using the Monaco RTP System for radiation treatment planning are affected. Patients receiving radiation therapy using these software versions may be at risk.
How to tell if you have this one
Check if you have the Monaco RTP System software versions 5.11.00, 5.11.01, 5.11.02, or 5.11.03. The UDI numbers include (01)00858164002169(10) followed by the software version.
- Brand
Elekta- Product
Elekta Inc recalls Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy- Category
Medical device
What to do — step by step
Contact Elekta
Reach out to Elekta for specific instructions on how to verify your software version and get the correct remedy.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Nationwide distribution in the US. International distribution to Albania, Algeria, Antigua and Barbuda, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegowina, Botswana, Brazil, Bulgaria,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 15 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-1233-2023 (February 28, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1233-2023 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.