BEUDAMED
    FDA Enforcement Class II Terminated

    IS4000 da Vinci Xi - Endoscope accessory; 0 Degree, 8mm Endoscope. Intuitive Surgical Inc.

    Recall: Z-1871-2014 · Reported July 2, 2014

    Enforcement

    Recall Number
    Z-1871-2014
    Event ID
    68531
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Intuitive Surgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 2, 2014
    Initiation Date
    June 11, 2014
    Classification Date
    June 25, 2014
    Termination Date
    July 2, 2014
    Address
    1266 Kifer Rd Bldg 100, N/A, Sunnyvale, CA, 94086-5304, United States

    Description

    IS4000 da Vinci Xi - Endoscope accessory; 0 Degree, 8mm Endoscope. Intuitive Surgical Inc.

    Reason

    In some procedures when using the endoscope in conjunction with the IS4000 (da Vinci Xi) System, the surgical view has an orange-yellow tint which can make it hard to differentiate between tissue

    Code Info

    470026-18

    Distribution

    Distributed in the states of FL, TX, and NY.

    Quantity

    19 units