UnratedMedical device recall · FDA · Published August 23, 2019
Elekta Monaco Radiation Planning Software Shows Wrong Anatomy Data
Elekta recalls Monaco radiation treatment software versions 5.50.00 and 5.51.00 due to incorrect anatomy and beam shift display in reports, which could lead to improper radiation targeting.
Monaco is displaying the Anatomy and Beam shift direction incorrectly on the Monaco Scan and Setup Reference Report and is DICOM exporting incorrect (Anatomy/Beam) shift directions.
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Contact the company
📍Recalling firmElekta, Inc.400 Perimeter Center Ter NE Ste 50 · Atlanta, GA 30346-1227
✎ GovInfoNow plain-language explainer
Elekta is recalling its Monaco radiation treatment planning software versions 5.50.00 and 5.51.00 because it displays incorrect anatomy and beam shift directions in reports. This could cause improper radiation targeting during treatment, potentially affecting patient safety. Read more at govinfonow.com/recall/67109-elekta-monaco-radiation-planning-software-shows-wrong-anatomy-data.
“Elekta Monaco Radiation Planning Software Shows Wrong Anatomy Data.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/67109-elekta-monaco-radiation-planning-software-shows-wrong-anatomy-data. Based on FDA recall #Z-2409-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2409-2019%22&limit=1).
The FDA announced on 2019-08-23 that Elekta, Inc. voluntarily recalled its Monaco Radiation Treatment Planning System (RTP) System because the software displays incorrect anatomy and beam shift directions. The agency stated the hazard involves incorrect DICOM exports of these shift directions.
How to tell if you have it
Monaco Radiation Treatment Planning System (RTP) System
The Monaco Radiation Treatment Planning System (RTP) System displays the Anatomy and Beam shift direction incorrectly on the Monaco Scan and Setup Reference Report. It also DICOM exports incorrect (Anatomy/Beam) shift directions.
Context
GovInfoNow's records show Elekta, Inc. has issued 39 other recalls since 2017-06-19. Recent Elekta recalls include the 2026-05-21 MOSAIQ Oncology System Software Recall for treatment plan loading risks, the 2026-04-03 Geneva Brachytherapy Applicator Recall for IU tube detachment risks, and the 2026-03-19 Leksell Vantage Arc System Recall for shifting coordinates during procedures. Other recent recalls of similar products include the 2026-02-06 Hitachi Proton Beam Therapy System Recall for positioning software anomaly risk, the 2025-11-28 RayStation/RayPlan Software Recall for radiation dose calculation errors, and the 2025-11-28 RayStation/RayPlan 10B Software Recall for radiation dose calculation risk.
How to tell if you have this one
Check if you have the Monaco Radiation Treatment Planning System software versions 5.50.00 or 5.51.00. The software build numbers are listed in the product description.
Brand
Elek: The brand name from the manufacturer title is
Product
Monaco Radiation Treatment Planning System (RTP) System
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify your Monaco software version by checking the build number in the product description.
Where it went and when
Where it was distributed
Distributed in Indiana and Ohio, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “Distribution within the US to Ohio and Indiana. International distribution to Germany, Greece, Sweden.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Indiana, Ohio.
Recall timeline
FDA terminated this recall 4.8 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-2409-2019 (August 23, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2409-2019 to see it in context.
Plain-language summary written by qwen3:4b on October 5, 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.