BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0457-2016 · Initiated October 28, 2015

    Recall

    Recall Number
    Z-0457-2016
    Event Number
    72619
    Firm
    BC Group International Inc
    FEI Number
    2939012
    Product Code
    DRL
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    October 28, 2015
    Posted
    December 22, 2015
    Terminated
    February 15, 2017
    Address
    3081 Elm Point Industrial Dr, Saint Charles, MO, 63301-4333

    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.

    Action

    The recalling firm issued return authorization numbers to the two customers who submitted complaints regarding the malfunctioning device. The customers sent back the units and the recalling firm replaced their devices with new units. On 10/29/2015, the recalling firm contacted their third customer by phone and informed them that the three devices they had in their possession were miswired which would cause the inverted ECG waveform. The recalling firm issued a return authorization number to their customer for the three devices. The recalling firm told their customer they would repair the devices and return them.

    Distribution

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

    Quantity

    5 units