Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2 Recalled by iCAD, Inc. Due to A device malfunction may cause the biopsy needle...
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 iCAD, Inc. directly.
Affected Products
DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2
Quantity: 153 devices
Why Was This Recalled?
A device malfunction may cause the biopsy needle to fail to reach the intended target. If location confirming radiographs are not taken and properly evaluated, biopsy site mislocation can result in non-target tissue being sampled rather than target tissue. May result in an incorrect diagnosis.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About iCAD, Inc.
iCAD, Inc. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report