BEUDAMED
    FDA Enforcement Class II Terminated

    Terumo 220/240V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog Number 801764

    Recall: Z-3243-2018 · Reported October 3, 2018

    Enforcement

    Recall Number
    Z-3243-2018
    Event ID
    80957
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Terumo Cardiovascular Systems Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 3, 2018
    Initiation Date
    August 28, 2018
    Classification Date
    September 25, 2018
    Termination Date
    April 23, 2020
    Address
    6200 Jackson Rd, Ann Arbor, MI, 48103-9586, United States

    Description

    Terumo 220/240V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog Number 801764

    Reason

    Screws on a Terumo¿ Advanced Perfusion System 1 Power Manager Board (the base unit circuit board) were not torqued to specification. It is possible that a screw which has not been properly torqued can go undetected during manufacturing testing and may loosen over time, resulting in the potential for an electrical short in the system

    Code Info

    Serial Numbers: 1522 1523 1524 1525 1528 1530 1526 1527 1532 1544 Spare Parts: 870509 ASSEMBLY POWER MANAGER POD APS S/N: 03097 03099 03100 03101 03113 03114 03115 03143 03155 03167 03264

    Distribution

    Nationwide Foreign: Mexico, BELGIUM, CANADA, India, Indonesia, Singapore, South Korea , Vietnam

    Quantity

    10 units