FDA-Device2015-03-11Class II
DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2
iCAD, Inc.
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.
Sold states
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.
Affected count
153 devices
Manufactured in
98 Spit Brook Rd, Suite 100, Nashua, NH, United States
Products
DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1243-2015Don't want to check this manually?
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