Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Monaco RTP System The Monaco system is used to make Recalled by Elekta, Inc. Due to When creating 3D plans using either MU or...
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 RTP 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 treatment plans and displays, on-screen and in hard-copy, two or three dimensional radiation dose distribution inside patients for given treatment plan set-ups
Quantity: 365
Why Was This Recalled?
When creating 3D plans using either MU or Dose weighting modes, if the user changes the Physician's Intent Rx Dose and/or the number of fractions, and then modifies the wedge angle, the MU value is scaled incorrectly.
Where Was This Sold?
This product was distributed to 11 states: CA, FL, KY, MD, MO, MT, NJ, NC, PA, WA, WI
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