BEUDAMED
    FDA Recall Terminated

    MelaFind Device, Model MF 100 US, optical diagnostic device for melanoma detection.

    Recall: Z-1636-2015 · Initiated April 2, 2015

    Recall

    Recall Number
    Z-1636-2015
    Event Number
    71127
    Firm
    MELA Sciences, Inc.
    FEI Number
    3002942014
    Product Code
    OYD
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 2, 2015
    Posted
    May 20, 2015
    Terminated
    May 4, 2016
    Address
    50 S Buckhout St, Ste 1, Irvington, NY, 10533-2204

    Description

    MelaFind Device, Model MF 100 US, optical diagnostic device for melanoma detection.

    Reason

    The probability and histogram data within the Melafind's device displayed user interface lacks approval (not included in the PMA supplement).

    Action

    The probability and histogram data within the Melafind's device displayed user interface is not included in the PMA supplement

    Distribution

    AL, CA, CT, CO, FL, HI, IL, MA, MD, MI, NH, NJ, NY, OH, PA, RI, SC, TN, TX, VA and WA

    Quantity

    65 units