BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1636-2015 · Reported May 27, 2015

    Enforcement

    Recall Number
    Z-1636-2015
    Event ID
    71127
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    MELA Sciences, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 27, 2015
    Initiation Date
    April 2, 2015
    Classification Date
    May 20, 2015
    Termination Date
    May 4, 2016
    Address
    50 S Buckhout St Ste 1, N/A, Irvington, NY, 10533-2204, United States

    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).

    Code Info

    UDI *+M709MF100US0/$$+7DN0123MAS*

    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