Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Focal Sim radiation therapy treatment planning system 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
Focal Sim radiation therapy treatment planning system
Quantity: 907
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