BEUDAMED
    FDA Enforcement Class II Terminated

    da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which contains a high Resolution Stereoscopic Viewer. Intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments.

    Recall: Z-0088-2014 · Reported November 6, 2013

    Enforcement

    Recall Number
    Z-0088-2014
    Event ID
    66434
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Intuitive Surgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    November 6, 2013
    Initiation Date
    October 17, 2011
    Classification Date
    October 28, 2013
    Termination Date
    October 28, 2013
    Address
    1266 Kifer Rd Bldg 100, N/A, Sunnyvale, CA, 94086-5304, United States

    Description

    da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which contains a high Resolution Stereoscopic Viewer. Intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments.

    Reason

    Improper restraints during transportation of the da Vinci system could cause the HRSV Monitor to become loose from its mount.

    Code Info

    model numbers 380610-04 through 38-610-14.

    Distribution

    Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Austria, Belgium, Canada, Chile, China, Denmark, Egypt, Finland, France, Greece, Germany, India, Indonesia, Israel, Ireland, Italy, Kuwait, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom.

    Quantity

    1,090 consoles