BEUDAMED
    FDA Recall Terminated

    DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2

    Recall: Z-1243-2015 · Initiated January 21, 2015

    Recall

    Recall Number
    Z-1243-2015
    Event Number
    70464
    Firm
    iCAD, Inc.
    FEI Number
    3026970882
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 21, 2015
    Posted
    March 4, 2015
    Terminated
    May 27, 2016
    Address
    98 Spit Brook Rd, Suite 100, Nashua, NH, 03062-5737

    Description

    DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2

    Reason

    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.

    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.

    Distribution

    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.

    Quantity

    153 devices