BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0381-2007 · Initiated November 8, 2006

    Recall

    Recall Number
    Z-0381-2007
    Event Number
    36963
    Firm
    Terumo Cardiovascular Systems Corp
    FEI Number
    1828100
    Product Code
    DTQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 8, 2006
    Posted
    February 1, 2007
    Terminated
    June 11, 2007
    Address
    6200 Jackson Rd, Ann Arbor, MI, 48103-9586

    Description

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

    Reason

    Following installation of software version 1.30 in October 2006, the firm confirmed a complaint that the new software caused a discrepancy in the pump speed calculation and caused the pump to stop during clinical use and a ''connect motor'' message to be displayed.

    Action

    Customers were notified by phone, fax, email or by a Terumo representative of these problems between 11/08/06 and 11/13/06 and instructed to not use the unit until new software had been installed. All version 1.30 software was replaced and version 1.40 installed prior to 12/4/06.

    Distribution

    Nationwide.

    Quantity

    35