BEUDAMED
    FDA Recall Terminated

    Terumo Advanced Perfusion System 1 Control Unit; Catalog number 801046.

    Recall: Z-0335-2007 · Initiated October 12, 2004

    Recall

    Recall Number
    Z-0335-2007
    Event Number
    36396
    Firm
    Terumo Cardiovascular Systems Corp
    FEI Number
    1828100
    Product Code
    DTQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 12, 2004
    Posted
    December 30, 2006
    Terminated
    February 1, 2007
    Address
    6200 Jackson Rd, Ann Arbor, MI, 48103-9586

    Description

    Terumo Advanced Perfusion System 1 Control Unit; Catalog number 801046.

    Reason

    Device module(s) may fail to properly initialize during start up, thus resulting in that single module being inoperable and a red 'X' being displayed on the monitor screen.

    Action

    U.S. consignees were sent an addendum to the operators manual on October 12, 2004 instructing them to cycle power to the unit to clear the error. International distributors were requested to provide this information to their customers on 12/15/04, but Terumo has not yet received confirmation that this was completed.

    Distribution

    Worldwide Distribution-USA and countries 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

    4,740 for all affected products