BEUDAMED
    FDA Recall Terminated

    Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base, Terumo Cardiovascular Systems, Ann Arbor, MI. Model 801764. (Not distributed within the United States). The device is indicated for use in the extracorporeal circulation of blood for arterial perfusion and cardiopulmonary bypass procedures by a perfusionist.

    Recall: Z-0910-2009 · Initiated November 7, 2008

    Recall

    Recall Number
    Z-0910-2009
    Event Number
    50554
    Firm
    Terumo Cardiovascular Systems Corporation
    FEI Number
    1828100
    Product Code
    DTQ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 7, 2008
    Posted
    February 24, 2009
    Terminated
    July 7, 2009
    Address
    6200 Jackson Road, Ann Arbor, MI, 48103-9586

    Description

    Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base, Terumo Cardiovascular Systems, Ann Arbor, MI. Model 801764. (Not distributed within the United States). The device is indicated for use in the extracorporeal circulation of blood for arterial perfusion and cardiopulmonary bypass procedures by a perfusionist.

    Reason

    The power manager board may cause a short circuit, resulting in loss of system power, loss of central control monitor or electrical arcing.

    Action

    An "Urgent Medical Device Correction" letter was sent to consignees on November 7, 2008. The letter described the reason for correction and provided instructions to customers. Terumo Cardiovascular Systems Corporation will replace the power manager boards on the affected devices. Customers were instructed to complete and fax the Customer Response Form to CVS Customer Service at 1-800-292-6551 (US only) or respond by telephone at 1-800-521-2818. Please direct questions to CVS Customers Service at 1-800-521-2818.

    Distribution

    Worldwide Distribution including USA and countries of Australia, Belgium, Canada, Columbia, Costa Rica, Dominican Republic, Egypt, Germany, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arab Emirates and Viet Nam.

    Quantity

    515