BEUDAMED
    FDA Enforcement Class II Ongoing

    The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller. Model Number: 372601-16.

    Recall: Z-2835-2018 · Reported August 22, 2018

    Enforcement

    Recall Number
    Z-2835-2018
    Event ID
    80691
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Intuitive Surgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 22, 2018
    Initiation Date
    May 17, 2018
    Classification Date
    August 16, 2018
    Address
    1266 Kifer Rd Bldg 101, Sunnyvale, CA, 94086-5304, United States

    Description

    The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller. Model Number: 372601-16.

    Reason

    An Endoscope Controller has been improperly calibrated during manufacturing. This improper calibration may result in the Endoscope Controller showing surgical images that are dimmer, have color imbalance or have reduced fluorescence and grayscale when using Firefly. There is also potential for increased fogging of the endoscope.

    Code Info

    UDI Number: 00886874114193. Serial Number: SK1703.

    Distribution

    U.S.

    Quantity

    1