DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2
FDA Recall Z-1243-2015 · Posted 2015-03-04
Recalling FirmiCAD, Inc.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2015-01-21
Date Terminated2016-05-27
Product Quantity153 devices
Reason for Recall
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.
Firm Action
iCAD notified Invivo of the recall via letter on January 21, 2015. Invivo sent a Customer Information letter dated January 23, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
The letters from both Invivo and iCAD (device manufacturer) recommend that DynaCAD Breast Interventional Software not be used with Invivo ds Breast 16 channel lateral grid plate part number 4535-303-31491. Invivo and iCAD are developing DynaCAD Breast Interventional 3.3 that corrects this error and will be available for installation beginning in March 2015.
If you need any further information or support concerning this issue, please contact your local Invivo representative:
1-877-Invivo1 (1-877-468-4861, option #3)
Invivo apologizes for any inconveniences caused by this problem.
Root Cause
Device Design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.