BEUDAMED
    FDA Enforcement Class II Terminated

    da Vinci Si Surgical System, IS3000; - Wall chart for EndoWrist Stapler 45 System. Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

    Recall: Z-1048-2015 · Reported February 11, 2015

    Enforcement

    Recall Number
    Z-1048-2015
    Event ID
    70181
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Intuitive Surgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 11, 2015
    Initiation Date
    January 15, 2015
    Classification Date
    February 3, 2015
    Termination Date
    March 3, 2015
    Address
    1266 Kifer Rd Bldg 100, N/A, Sunnyvale, CA, 94086-5304, United States

    Description

    da Vinci Si Surgical System, IS3000; - Wall chart for EndoWrist Stapler 45 System. Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

    Reason

    The Wall chart has been updated because it was noted that Wall Chart (PN 551524-03 Rev A) was inconsistent with the User Manual Adendum (PN 550986-07_B) with regards to neceassary sterilization dry time.

    Code Info

    PN 410298-05, -06, -07, -08, -09

    Distribution

    Nationwide Distribution

    Quantity

    1,034