BEUDAMED
    FDA Recall Terminated

    Intuitive brand Da Vinci S Surgical System, an Endoscopic Instrument Control System, Model SS2000 Patient Side Cart, Model PS2000, Part Number: 380267-01, IS2000, Top Level, 4-Arm; Distributed and Manufactured by: Intuitive Surgical, Inc. 950 Kifer Road Sunnyvale, CA

    Recall: Z-0670-2007 · Initiated April 12, 2006

    Recall

    Recall Number
    Z-0670-2007
    Event Number
    37431
    Firm
    Intuitive Surgical, Inc.
    FEI Number
    3001675293
    Product Code
    NAY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 12, 2006
    Posted
    March 29, 2007
    Terminated
    December 5, 2007
    Address
    950 Kifer Rd, Sunnyvale, CA, 94086-5206

    Description

    Intuitive brand Da Vinci S Surgical System, an Endoscopic Instrument Control System, Model SS2000 Patient Side Cart, Model PS2000, Part Number: 380267-01, IS2000, Top Level, 4-Arm; Distributed and Manufactured by: Intuitive Surgical, Inc. 950 Kifer Road Sunnyvale, CA

    Reason

    Da Vinci S Surgical System's spinal pin could limit mechanical motion of the arm and render the system unavailable for surgical use, and may result in system failure and the need to convert to an alternative surgical technique.

    Action

    The firm did not release notification to its consignees. The reworks were arranged as part of routine service visits initiated on 4/12/06.

    Distribution

    Nationwide.

    Quantity

    24 units