BEUDAMED
    FDA Recall Terminated

    Terumo Advanced Perfusion System 1 Integrated Centrifugal System Control Unit; Catalog No. 801046.

    Recall: Z-1405-06 · Initiated June 30, 2006

    Recall

    Recall Number
    Z-1405-06
    Event Number
    34487
    Firm
    Terumo Cardiovascular Systems Corp
    FEI Number
    1828100
    Product Code
    DTQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 30, 2006
    Posted
    August 22, 2006
    Terminated
    June 19, 2008
    Address
    6200 Jackson Rd, Ann Arbor, MI, 48103-9586

    Description

    Terumo Advanced Perfusion System 1 Integrated Centrifugal System Control Unit; Catalog No. 801046.

    Reason

    The roller pump speed control knobs and the centrifugal pump speed control knobs may fail to function/change pump speed.

    Action

    The firm replaced the graphics driver board on complaint units as user complaints were received. The firm notified all users of the problem and the presence of an alternative method of pump speed control via recall letter dated 6/30/06.

    Distribution

    Worldwide-USA, Australia, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South Korea, Thailand and United Arab Emirates.

    Quantity

    Recall Numbers Z-1403-1405-2006 -1,135 systems in the U.S. plus 723 internationally.