Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Oncentra Brachy radiation therapy planning software designed to analyze and Recalled by Elekta, Inc. Due to Incorrect dose calculation for Regions of Interest (ROIs)...
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
Oncentra Brachy radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.
Quantity: 351
Why Was This Recalled?
Incorrect dose calculation for Regions of Interest (ROIs) defined on a secondary image series.
Where Was This Sold?
This product was distributed to 41 states: AL, AZ, AR, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WV, 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