BEUDAMED
    FDA Enforcement Class III Terminated

    TAPSYSTEM Model 2A, REF 8002A

    Recall: Z-1976-2019 · Reported July 24, 2019

    Enforcement

    Recall Number
    Z-1976-2019
    Event ID
    83173
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cardiocommand Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 24, 2019
    Initiation Date
    June 24, 2019
    Classification Date
    July 15, 2019
    Termination Date
    April 1, 2021
    Address
    4920 W Cypress St Ste 110, N/A, Tampa, FL, 33607-3837, United States

    Description

    TAPSYSTEM Model 2A, REF 8002A

    Reason

    There is a potential for an assembly error resulting in the battery wire being connected to the ON/OFF power switch incorrectly.

    Code Info

    SERIAL NUMBERS: 2197A, 2196A, 2198A, 2199A, 2200A, and 2201A,

    Distribution

    United States - AR, NM, PA, TX, and WA.

    Quantity

    6 units