iCAD, Inc. recalls DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2

Recall date

January 21, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1243-2015

FDA classification

Class II

Brand / firm

iCAD, Inc.

Sold / distributed

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…

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2