BEUDAMED
    FDA Enforcement Class II Terminated

    IS3000 USER MANUAL for Intuitive Surgical da Vinci Si Surgical System and da Vinci Si-e Surgical System, Model SI3000. Arm drapes protect equipment from contamination.

    Recall: Z-1110-2013 · Reported April 24, 2013

    Enforcement

    Recall Number
    Z-1110-2013
    Event ID
    64755
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Intuitive Surgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 24, 2013
    Initiation Date
    March 15, 2013
    Classification Date
    April 13, 2013
    Termination Date
    September 4, 2014
    Address
    1266 Kifer Rd Bldg 100, N/A, Sunnyvale, CA, 94086-5304, United States

    Description

    IS3000 USER MANUAL for Intuitive Surgical da Vinci Si Surgical System and da Vinci Si-e Surgical System, Model SI3000. Arm drapes protect equipment from contamination.

    Reason

    Revised instructions for users of the da Vinci S, Si and Si-e systems with additional information regarding sterile adapter engagement and instrument installation.

    Code Info

    Model number 550650-05 (P8)

    Distribution

    Worldwide Distribution.-USA (nationwide) and countries of: Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Netherlands, Norway, South Korea, Sweden, Switzerland, and United Kingdom.

    Quantity

    1642 customers