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iCAD, Inc. recalls DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2
Recalled March 11, 2015 · FDA recall Z-1243-2015 · iCAD
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. · FDA Class II
Units
153 devices
Sold at
Worldwide Distribution - Nationwide Distribution to the states of : AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NH, NJ, NY, OR, PA, SC, TN, TX, VA, VT, WA, WI, WV and W., and to the countries of : BELGIUM, GERMANY, GREAT BRITAIN, INDIA, ISRAEL, NETHERLANDS and SWITZERLAND.
Description
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.
Product
DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2
Manufacturer(s)
iCAD, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →