BEUDAMED
    FDA Enforcement Class II Ongoing

    Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.

    Recall: Z-1428-2026 · Reported February 25, 2026

    Enforcement

    Recall Number
    Z-1428-2026
    Event ID
    98200
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Intuitive Surgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 25, 2026
    Initiation Date
    November 17, 2025
    Classification Date
    February 18, 2026
    Address
    1266 Kifer Rd, Sunnyvale, CA, 94086-5304, United States

    Description

    Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.

    Reason

    An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external monitor or tower monitor.

    Code Info

    UDI-DI: 00886874119747 GTIN: 0886874119747 with software version P1.2.1

    Distribution

    US distribution: LA, MA, NY, PA, TX, and VA.

    Quantity

    12