BEUDAMED
    FDA Recall Terminated

    Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required); Models 801763 and 801763 (Japan unit).

    Recall: Z-1286-06 · Initiated October 19, 2005

    Recall

    Recall Number
    Z-1286-06
    Event Number
    34490
    Firm
    Terumo Cardiovascular Systems Corp
    FEI Number
    1828100
    Product Code
    DTQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 19, 2005
    Posted
    July 27, 2006
    Terminated
    June 19, 2008
    Address
    6200 Jackson Rd, Ann Arbor, MI, 48103-9586

    Description

    Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required); Models 801763 and 801763 (Japan unit).

    Reason

    While on battery power, the system may flash a low battery warning even though the battery is adequately charged.

    Action

    Customers were notified via letter dated October 19, 2005 that the Power Manager Software would be upgraded within the next six months. As of 7/7/06 all units within the U.S. have been completed and international units are still in the process of being upgraded.

    Distribution

    Nationwide and worldwide, including Australia, Belgium, Canada, China, Dominican Republic, Egypt, Georgia, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South Korea, Thailand, Turkey and United Arab Emirates.

    Quantity

    329