BEUDAMED
    FDA Recall Terminated

    TAPSYSTEM Model 2A, REF 8002A

    Recall: Z-1976-2019 · Initiated June 24, 2019

    Recall

    Recall Number
    Z-1976-2019
    Event Number
    83173
    Firm
    Cardiocommand Inc.
    FEI Number
    1927197
    Product Code
    LPA
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 24, 2019
    Terminated
    April 1, 2021
    Address
    4920 W Cypress St, Ste 110, Tampa, FL, 33607-3837

    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.

    Action

    On June 24, the firm plans to send URGENT MEDICAL DEVICE letters to six consignees that will advise them of the issue, request that they either return their device or perform an ON/OFF switch verification procedure, and to return the attached REPLY FORM.

    Distribution

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

    Quantity

    6 units