BEUDAMED
    FDA Recall Terminated

    Low-Level Output Cable. The device is used to allow the information displayed on the Intra-aortic balloon pump (IABP) to be displayed on a separate patient monitor.

    Recall: Z-1198-2009 · Initiated February 4, 2009

    Recall

    Recall Number
    Z-1198-2009
    Event Number
    51178
    Firm
    Datascope Corporation
    FEI Number
    1000222374
    Product Code
    DSP
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    February 4, 2009
    Posted
    April 15, 2009
    Terminated
    August 11, 2009
    Address
    15 Law Dr, Fairfield, NJ, 07004-0011

    Description

    Low-Level Output Cable. The device is used to allow the information displayed on the Intra-aortic balloon pump (IABP) to be displayed on a separate patient monitor.

    Reason

    Non-functioning cable: the Low-Level Output Cable when connected to a Datascope Intra-aortic Ballon Pump (IABP) and patient monitor does not provide a signal to the patient monitor.

    Action

    An "Urgent Medical Device Recall" letter dated February 4, 2009 was delivered to affected consignees by Datascope Field Representatives. Direct questions to your local Sales/Service Representative or call the Datascope Corporation at 1-973-244-6314.

    Distribution

    Nationwide Distribution -- states of IL and FL.

    Quantity

    20