Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Monaco RTP System Used to make treatment plans for patients Recalled by Elekta, Inc. Due to In a specific workflow where contours are edited...
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 Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Quantity: 3,012 units
Why Was This Recalled?
In a specific workflow where contours are edited (enlarged, moved, copied, etc.) and then the contour is deleted on some slices and saved in the same session, it is possible that the deleted contours are still present which would not be the intent of the planner.
Where Was This Sold?
This product was distributed to 39 states: AK, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MD, MA, MI, MN, MO, MT, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, DC
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