BEUDAMED
    FDA Recall Terminated

    Intuitive Surgical, daVinci S Surgical System, Model Number: IS2000, A5.1 P1 and A5.0 P5 software level, Surgical Endoscopic Instrument Control System, Intuitive Surgical, Sunnyvale, CA 94086.

    Recall: Z-0079-2008 · Initiated March 30, 2007

    Recall

    Recall Number
    Z-0079-2008
    Event Number
    38311
    Firm
    Intuitive Surgical, Inc.
    FEI Number
    3001675293
    Product Code
    NAY
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 30, 2007
    Posted
    February 21, 2008
    Terminated
    September 5, 2008
    Address
    950 Kifer Rd, Sunnyvale, CA, 94086-5206

    Description

    Intuitive Surgical, daVinci S Surgical System, Model Number: IS2000, A5.1 P1 and A5.0 P5 software level, Surgical Endoscopic Instrument Control System, Intuitive Surgical, Sunnyvale, CA 94086.

    Reason

    System Lock-Up: Software anomalies could cause product failure during use, or on start-up. System transitions to a safe "soft-lock" state.

    Action

    Intuitive Field Service Engineers installed a software upgrade beginning on 03/30/2007, and left a notification letter that the upgrade had been performed at each site. New software level is A5.1 P2.

    Distribution

    Worldwide Distribution - USA, Belgium, China, France, India, Italy, Japan, Korea, Spain, Sweden, Switzerland, UK and Mexico.

    Quantity

    159