BEUDAMED
    FDA Enforcement Class III Terminated

    DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output of a defibrillator or transcutaneous pacemaker.

    Recall: Z-0457-2016 · Reported December 30, 2015

    Enforcement

    Recall Number
    Z-0457-2016
    Event ID
    72619
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    BC Group International Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    December 30, 2015
    Initiation Date
    October 28, 2015
    Classification Date
    December 21, 2015
    Termination Date
    February 15, 2017
    Address
    3081 Elm Point Industrial Dr, N/A, Saint Charles, MO, 63301-4333, United States

    Description

    DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output of a defibrillator or transcutaneous pacemaker.

    Reason

    Device is not functioning as intended: Two wires running to the ECG distribution circuit board are reversed resulting in inverted waveforms.

    Code Info

    SN: 73962222, 73962223, 73962224, 73962225, and 73962226

    Distribution

    US Nationwide Distribution in the states of South Carolina, Florida, and Canada.

    Quantity

    5 units