BEUDAMED
    FDA Enforcement Class II Terminated

    The ZYTO Select and ZYTO Elite software programs are used to rank pairs of galvanic skin response measurements from most coherent (the second scan is closest in time measurement to the baseline original scan) to least coherent (further away from the baseline).

    Recall: Z-2121-2016 · Reported July 13, 2016

    Enforcement

    Recall Number
    Z-2121-2016
    Event ID
    74273
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ZYTO Technologies, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    July 13, 2016
    Initiation Date
    November 23, 2015
    Classification Date
    July 1, 2016
    Termination Date
    December 21, 2017
    Address
    387 S 520 W Ste 200, N/A, Lindon, UT, 84042-1961, United States

    Description

    The ZYTO Select and ZYTO Elite software programs are used to rank pairs of galvanic skin response measurements from most coherent (the second scan is closest in time measurement to the baseline original scan) to least coherent (further away from the baseline).

    Reason

    ZYTO Technologies Inc. Announces a Voluntary Recall of the ZYTO Tower and ZYTO Select and Elite Software Due to Claims Exceeding the 510(k) Clearance.

    Code Info

    Not Applicable.

    Distribution

    Nationwide. Canadian and other foreign consignees. No VA/govt/military.

    Quantity

    1252 total