BEUDAMED
    FDA Enforcement Class II Terminated

    Control Panel REF - 60-02-50: LivaNova SCP Pump Control Panel S5/C5. REF 60-02-50, IPX2, RxOnly, UDI: 04033817900993

    Recall: Z-2439-2020 · Reported July 8, 2020

    Enforcement

    Recall Number
    Z-2439-2020
    Event ID
    85505
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    LivaNova Deutschland GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 8, 2020
    Initiation Date
    August 26, 2019
    Classification Date
    June 26, 2020
    Termination Date
    April 22, 2021
    Address
    Lindberghstr. 25, N/A, Munich, N/A, N/A, Germany

    Description

    Control Panel REF - 60-02-50: LivaNova SCP Pump Control Panel S5/C5. REF 60-02-50, IPX2, RxOnly, UDI: 04033817900993

    Reason

    The SCP control Panel rotary knob used to control rotary speed of the pump in the SCP system used as a centrifugal pump during cardiopulmonary bypass may be difficult or impossible to rotate as a result of premature wear of the angle encoder. The loss of function of the angle encoder during bypass may lead to ischemia, stroke, organ damage, arterial tissue injury or reperfusion syndrome.

    Code Info

    Serial Number: 60S14735 60S14877 60S14715 60S14716 60S14736 60S14755 60S14707 60S14708

    Distribution

    US: FL, GA, IN, KY, MI, MO, NY, OH, PA, SC, TN, TX, VA OUS: Canada - Uzbekistan - Turkey - Tunisia - Taiwan - South Africa - Serbia - Saudi Arabia - Russia - Poland - Mexico - Korea(Rep. of) - India - Hong Kong - Colombia - China - Brazil - Bahrain - Argentina - Algeria - Italy - Germany

    Quantity

    8