BEUDAMED
    FDA Enforcement Class II Terminated

    Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188

    Recall: Z-2350-2021 · Reported September 1, 2021

    Enforcement

    Recall Number
    Z-2350-2021
    Event ID
    88350
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Terumo Cardiovascular Systems Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 1, 2021
    Initiation Date
    June 8, 2021
    Classification Date
    August 26, 2021
    Termination Date
    June 28, 2022
    Address
    6200 Jackson Rd, N/A, Ann Arbor, MI, 48103-9586, United States

    Description

    Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188

    Reason

    intermittent failure causes a blender initialization fault upon start-up, or during an EPGS calibration attempt following the 15-minute warm-up period. The control sliders on the Central Control Monitor (CCM) are disabled and the gas system can only be controlled by the local control knobs

    Code Info

    S/N: 01751 UDI: 00886799000588

    Distribution

    International distribution in the country of Panama.

    Quantity

    1 unit OUS