BEUDAMED
    FDA Enforcement Class II Terminated

    User Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and IS 3000. Product Usage: The user manual for Transoral Surgery (TORS) provided information to update and replace the Indications for Use and Representative uses section and add the section Warnings for Transoral Otolaryngology Surgery.

    Recall: Z-1424-2013 · Reported June 5, 2013

    Enforcement

    Recall Number
    Z-1424-2013
    Event ID
    65094
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Intuitive Surgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 5, 2013
    Initiation Date
    January 24, 2013
    Classification Date
    May 29, 2013
    Termination Date
    May 30, 2013
    Address
    1266 Kifer Rd Bldg 100, N/A, Sunnyvale, CA, 94086-5304, United States

    Description

    User Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and IS 3000. Product Usage: The user manual for Transoral Surgery (TORS) provided information to update and replace the Indications for Use and Representative uses section and add the section Warnings for Transoral Otolaryngology Surgery.

    Reason

    Change to User Manual to remove one indication for use and amend warnings to emphasize restrictions for use.

    Code Info

    Model number 552002-01

    Distribution

    US Distribution Only

    Quantity

    1,374