FDAJanuary 21, 2015device
DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
icad
Recall history
No related federal recalls on record for this brand yet.
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