BEUDAMED
    FDA Enforcement Class II Terminated

    Patient Side Cart Battery Box used in conjunction with the da Vinci A surgical system. Intuitive Surgical Inc. Sunnyvale, CA 94086

    Recall: Z-1994-2014 · Reported July 16, 2014

    Enforcement

    Recall Number
    Z-1994-2014
    Event ID
    68593
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Intuitive Surgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    July 16, 2014
    Initiation Date
    April 27, 2012
    Classification Date
    July 4, 2014
    Termination Date
    July 7, 2014
    Address
    1266 Kifer Rd Bldg 100, Sunnyvale, CA, 94086-5304, United States

    Description

    Patient Side Cart Battery Box used in conjunction with the da Vinci A surgical system. Intuitive Surgical Inc. Sunnyvale, CA 94086

    Reason

    Patient Side Cart battery boxes may overheat in rare charging conditions, causing battery bulging.

    Code Info

    Material number 371268-02 - al lots.

    Distribution

    Worldwide Distribution.

    Quantity

    2606