Elekta Monaco RTP System Software Builds 5.40.00-5.51.10 Recall: Dose Calculation Risk
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.
Lower-risk recall
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.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/62160-elekta-monaco-rtp-system-software-builds-5-40-00-5.
Source Summary by GovInfoNow · govinfonow.com/recall/62160-elekta-monaco-rtp-system-software-builds-5-40-00-5 · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2406-2021
Cite this page
“Elekta Monaco RTP System Software Builds 5.40.00-5.51.10 Recall: Dose Calculation Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62160-elekta-monaco-rtp-system-software-builds-5-40-00-5. Based on FDA recall #Z-2406-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2406-2021%22&limit=1).
Why it’s dangerous
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.
Who’s affected
Medical professionals using Elekta's Monaco RTP System for radiation therapy treatment planning. Those with the specific software builds listed are most at risk.
How to tell if you have this one
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.
- Brand
Elekta- Product
Elekta Inc recalls Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10- Category
Medical device
What to do — step by step
Check Software Version
Verify your Monaco RTP System software version matches the recalled builds (5.40.00, 5.40.01, 5.40.02, or 5.51.10).
Where it went and when
Where it was distributed
Distributed in 7 states, and outside the U.S.
FDA distribution: “Distribution in US - IA, NJ, NY, TN, PA, TX, and WI OUS distribution in Australia, Bahrain, Belgium, Canada, China, Denmark, France, Germany, Hong Kong, Italy, Japan, Korea, Netherlands, Spain, Sweden, Switzerland, Thailand, Turkey and…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Iowa, New Jersey, New York, Pennsylvania, Tennessee, Texas, Wisconsin.
Recall timeline
FDA published this recall 44 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-2406-2021 (July 26, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2406-2021 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.