BEUDAMED
    FDA Recall Terminated

    da Vinci S Surgical System, Model number IS2000 Revision number A51 P5; endoscopic surgical control system, Intuitive Surgical, Inc., Sunnyvale, CA 94086

    Recall: Z-1180-2008 · Initiated December 27, 2007

    Recall

    Recall Number
    Z-1180-2008
    Event Number
    46716
    Firm
    Intuitive Surgical, Inc.
    FEI Number
    3001675293
    Product Code
    NAY
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 27, 2007
    Posted
    June 12, 2008
    Terminated
    August 15, 2008
    Address
    950 Kifer Rd, Sunnyvale, CA, 94086-5206

    Description

    da Vinci S Surgical System, Model number IS2000 Revision number A51 P5; endoscopic surgical control system, Intuitive Surgical, Inc., Sunnyvale, CA 94086

    Reason

    Delay in responding: In certain circumstances, the device may not respond immediately to a user's command such as master clutch or camera control.

    Action

    Beginning 12/28/2007, Intuitive Surgical Field Service Representatives visited each site to correct the issues. A notification letter was provided to all sites.

    Distribution

    USA Distribution: TX, NJ, WA, NV, HI, MI, NH and CA

    Quantity

    9 units