Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Monaco radiation therapy treatment planning system. The Monaco system is Recalled by Elekta, Inc. Due to Incorrect CT to ED when using the Monaco...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Elekta, Inc. directly.
Affected Products
Monaco radiation therapy treatment planning system. The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon and electron treatment plans and displays, on-screen and in hard-copy, two or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups.
Quantity: 1354
Why Was This Recalled?
Incorrect CT to ED when using the Monaco Image Statistics Tool.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Elekta, Inc.
Elekta, Inc. has 100 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report