Elekta recalls Monaco RTP radiation treatment software version 5.40.00 and 5.40.01 due to potential inaccurate radiation dose delivery. Affected users should contact Elekta for details.
The Monaco RTP Radiation Treatment Planning System may change the shape and volume of the contour potentially resulting in the device delivering an inaccurate dose.
Take action
Contact the company
📍Recalling firmElekta Inc1450 Beale St Ste 205 · Saint Charles, MO 63303
✎ GovInfoNow plain-language explainer
Elekta is recalling its Monaco RTP radiation treatment planning software versions 5.40.00 and 5.40.01 because it may deliver inaccurate radiation doses to patients. This could lead to improper treatment outcomes if the software changes the shape and volume of the treatment contour. Read more at govinfonow.com/recall/65393-elekta-monaco-rtp-software-recall-inaccurate-radiation-dose-risk.
“Elekta Monaco RTP Software Recall: Inaccurate Radiation Dose Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65393-elekta-monaco-rtp-software-recall-inaccurate-radiation-dose-risk. Based on FDA recall #Z-1825-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1825-2020%22&limit=1).
The FDA announced on April 16, 2020, that Elekta Inc. is recalling its MONACO RTP System radiation treatment planning software due to a hazard where the system may change contour shape and volume, potentially resulting in an inaccurate radiation dose delivery.
How to tell if you have it
Brand: Elekta
Product: MONACO RTP Sytem, radiation treatment planning software system
According to the FDA, the Monaco RTP Radiation Treatment Planning System may change the shape and volume of the contour, potentially resulting in the device delivering an inaccurate dose. The system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Context
GovInfoNow's records show Elekta, Inc. has had 39 other recalls on record since June 19, 2017. Other recent recalls of similar products include the Elekta MOSAIQ Oncology System Software Recall (May 21, 2026), the Elekta Fletcher CT/MR Shielded Applicator Set Recall (April 3, 2026), and the Elekta Leksell Vantage Arc System Recall (March 19, 2026). Other recent recalls of similar products include the RayStation/RayPlan 10B Software Recall (November 28, 2025), the RayStation/RayPlan Software Recall (November 28, 2025), and the RayStation/RayPlan Software 11A Recalls (November 28, 2025).
How to tell if you have this one
Check for software versions 5.40.00 or 5.40.01 in the Monaco RTP system. The software build numbers are listed in the product description.
Identify the software version by checking the build number in the Monaco RTP system.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 6 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide Distribution in the states of IA, NJ, NY, PA, TX, WI and the countries of Australia, Canada, China, Denmark, Germany, Hong Kong, Italy, Netherlands, Sweden, Switzerland, Thailand, Turkey, United…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Iowa, New Jersey, New York, Pennsylvania, Texas, Wisconsin.
Recall timeline
FDA published this recall 20 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-1825-2020 (April 16, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1825-2020 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.