BEUDAMED
    FDA Recall Terminated

    Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required); Model 801764. (Not distributed within the United States).

    Recall: Z-0315-2007 · Initiated May 1, 2004

    Recall

    Recall Number
    Z-0315-2007
    Event Number
    36395
    Firm
    Terumo Cardiovascular Systems Corp
    FEI Number
    1828100
    Product Code
    DTQ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 1, 2004
    Posted
    December 27, 2006
    Terminated
    July 14, 2009
    Address
    6200 Jackson Rd, Ann Arbor, MI, 48103-9586

    Description

    Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required); Model 801764. (Not distributed within the United States).

    Reason

    The gas system may fail calibration prior to use due to incorrect gas system flowmeter software.

    Action

    U.S. consignees were visited and corrections made between May 2004 and November 2005. Foreign affiliates were instructed to make corrections on international units, but the firm has not received confirmation yet that these units have been corrected.

    Distribution

    Worldwide distribution, including USA, Belgium, Germany, Japan, Korea and Republic of China.

    Quantity

    5