Lower riskMedical device recall · FDA · Published February 8, 2019
Elekta Monaco Radiation Treatment System Recall: Risk of Incorrect Dose Calculation
Elek: Monaco radiation treatment software version 5.40 may use incorrect dose optimization models during plan adaptation. Affected users should contact Elekta for details.
If Improve Target Dose was chosen as an optimization model in a previous treatment session, Monaco¿ will automatically use this optimization model again when proceeding with the online plan adaptation of a completion plan when it should not.
Take action
Contact the company
📍Recalling firmElekta, Inc.400 Perimeter Center Ter NE Ste 50 · Atlanta, GA 30346-1227
“Elekta Monaco Radiation Treatment System Recall: Risk of Incorrect Dose Calculation.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69028-elekta-monaco-radiation-treatment-system-recall-risk-of-incorrect-dose. Based on FDA recall #Z-0965-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0965-2019%22&limit=1).
The FDA announced on Feb. 8, 2019, that Elekta, Inc. voluntarily recalled its Monaco Radiation Treatment Planning (RTP) System software version 5.40 due to a Class II hazard. The device may automatically use an incorrect optimization model during online plan adaptation when it should not.
How to tell if you have it
Brand: Elekta
Product: Monaco Radiation Treatment Planning (RTP) System
Software version: 5.40
Quantity: 14 devices
The hazard
According to the FDA, if Improve Target Dose was chosen as an optimization model in a previous treatment session, Monaco will automatically use this optimization model again when proceeding with the online plan adaptation of a completion plan when it should not.
Context
GovInfoNow's records show Elekta, Inc. has had 39 other recalls on record since June 19, 2017. Recent Elekta recalls include the MOSAIQ Oncology System Software Recall on May 21, 2026, and the Fletcher CT/MR Shielded Applicator Set Recall on April 3, 2026. Other recent recalls of similar products include RayStation/RayPlan 10B Software Recall (Nov. 28, 2025) and RayStation/RayPlan Software 11A Recalls (Nov. 28, 2025).
How to tell if you have this one
Check if you have Elekta's Monaco software version 5.40. Look for previous use of the 'Improve Target Dose' optimization model in treatment sessions.
Brand
Elekta
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Contact Elekta
Reach out to Elekta directly for specific guidance on whether your software version is affected and next steps.
Where it went and when
Where it was distributed
Distributed in Texas and Wisconsin, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “Domestic distribution to Wisconsin, Texas. International distribution to Denmark, England, Germany, Netherlands, Sweden.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Texas, Wisconsin.
Recall timeline
FDA terminated this recall 5.5 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-0965-2019 (February 8, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0965-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.