Lower riskMedical device recall · FDA · Published September 14, 2021
Elekta Monaco Software Recalls: Contour Changes May Save Unintended Image Sets
Elekta recalls Monaco radiation treatment software versions 5.40.00-5.40.02 and 5.51.10 due to potential unintended contour changes saving image sets, which could affect radiation treatment plans.
Contour changes can be saved on an unintended image set. In addition, these contour edits do not cause the dose to be frozen on the plans associated with that image set.
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Contact the company
📍Recalling firmElekta Inc1450 Beale St Ste 205 · Saint Charles, MO 63303
“Elekta Monaco Software Recalls: Contour Changes May Save Unintended Image Sets.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61800-elekta-monaco-software-recalls-contour-changes-may-save-unintended-image. Based on FDA recall #Z-2563-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2563-2021%22&limit=1).
The FDA announced on Sept. 14, 2021, that Elekta Inc. is recalling its Monaco software due to a hazard where contour changes may be saved on an unintended image set without freezing the dose. The agency classified this Class II recall as voluntary and ongoing.
According to the FDA, contour changes can be saved on an unintended image set. In addition, these contour edits do not cause the dose to be frozen on the plans associated with that image set.
Context
GovInfoNow's records show Elekta, Inc. has had 39 other recalls since June 19, 2017. Recent brand recalls include the May 21, 2026, MOSAIQ Oncology System Software Recall and the April 3, 2026, Fletcher CT/MR Shielded Applicator Set Recall. Other recent recalls of similar products include the Nov. 28, 2025, RayStation Software Recalls for radiation dose calculation errors and the Nov. 28, 2025, RayStation/RayPlan 10B Software Recall.
How to tell if you have this one
Check for software versions 5.40.00, 5.40.01, 5.40.02, or 5.51.10 in the Elekta Monaco system. The software is used for creating radiation treatment plans for patients with prescriptions for external beam radiation therapy.
Brand
Elekta
Product
Elekta Inc recalls Elekta Monaco
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Update Software
Install the latest software version from Elekta to fix the contour saving issue.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 8 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of PA, MI, WI, NY, TN, NJ, IA, TX and the countries of United Kingdom, Turkey, Switzerland, Sweden, Spain, Netherlands, Korea, Thailand, Japan, Italy, Hong Kong, Germany,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Iowa, Michigan, New Jersey, New York, Pennsylvania, Tennessee, Texas, Wisconsin.
Recall timeline
FDA published this recall 22 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-2563-2021 (September 14, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2563-2021 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.