BEUDAMED
    FDA Recall Terminated

    The ZYTO Tower is the input device to program the software with various virtual items.

    Recall: Z-2120-2016 · Initiated November 23, 2015

    Recall

    Recall Number
    Z-2120-2016
    Event Number
    74273
    Firm
    ZYTO Technologies, Inc.
    FEI Number
    3008493238
    Product Code
    GZO
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    November 23, 2015
    Terminated
    December 21, 2017
    Address
    387 S 520 W, Ste 200, Lindon, UT, 84042-1961

    Description

    The ZYTO Tower is the input device to program the software with various virtual items.

    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.

    Action

    Consignees were notified on 11/23/2015 via letter and email of an update to the ZYTO Select and Elite Software that would disable all tower functionality..

    Distribution

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

    Quantity

    1252 total