BEUDAMED
    FDA Recall Terminated

    Ventilator System SERVO-i V3.1 PC1777 Maquet Critical Care

    Recall: Z-0372-2007 · Initiated May 23, 2006

    Recall

    Recall Number
    Z-0372-2007
    Event Number
    37089
    Firm
    MAQUET Inc.
    FEI Number
    3008355164
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 23, 2006
    Posted
    January 25, 2007
    Terminated
    April 11, 2008
    Address
    1140 US Highway 22, Bridgewater, NJ, 08807-2958

    Description

    Ventilator System SERVO-i V3.1 PC1777 Maquet Critical Care

    Reason

    Reported failures of the SERVO-i ventilators user interface system causing technical errors and increased fault frequencies. Switches may be activated unintentionally, or a function not activate when the switch is selected. Direct access knobs may not function or change the parameter in the wrong direction compared to how they are turned.

    Action

    Maquet sent an ''Extended Warranty'' letter on May 23, 2006. On March 13, 2007, Maquet issued a Recall Notification letter to all customers stating that they will replace all PC1777 boards in the serial number range 2400-3300, which have not previously been replaced. A safety alert letter was included outlining the failure indication and effect for the user of the failures, as well as, how to identify whether the Servo-i unit has shown any failure indications.

    Distribution

    Worldwide

    Quantity

    1, 970 units