BEUDAMED
    FDA Enforcement Class II Ongoing

    Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgical System, REF: IS4200; Patient Side Cart, REF: 380652, with instrument arms, used as part of the da Vinci Xi Surgical System, REF: IS4000

    Recall: Z-1262-2023 · Reported March 22, 2023

    Enforcement

    Recall Number
    Z-1262-2023
    Event ID
    91505
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Intuitive Surgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 22, 2023
    Initiation Date
    January 24, 2023
    Classification Date
    March 16, 2023
    Address
    1266 Kifer Rd Bldg 101, N/A, Sunnyvale, CA, 94086-5304, United States

    Description

    Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgical System, REF: IS4200; Patient Side Cart, REF: 380652, with instrument arms, used as part of the da Vinci Xi Surgical System, REF: IS4000

    Reason

    Preventative maintenance data was used to identify instrument Arms, part of surgical systems, that allow surgeons to perform surgical tasks, that may be at risk of insertion ballscrew failure, allowing for uncontrolled carriage movement along the insertion axis, which may cause tissue injury.

    Code Info

    System REF: Serial Numbers/Cart REF/UDI-DI/Arm Serial Numbers: IS4200: SL0379, SL0069/ 380620/ 00886874115404/ 668080, 575093, IS4000: SK1402, SK0991, SK2332, SK0744, SK0110, SK0753/380652 / 00886874110720/ 372054, 663693, 557322, 547953, 425439, 409962

    Distribution

    Worldwide - US Nationwide distribution in the states of FL, GA, WA and the countries of United Kingdom, Germany, France

    Quantity

    9