BEUDAMED
    FDA Enforcement Class II Ongoing

    Allia Moveo angiographic X-ray system

    Recall: Z-2318-2026 · Reported June 17, 2026

    Enforcement

    Recall Number
    Z-2318-2026
    Event ID
    98880
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    GE Medical Systems, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 17, 2026
    Initiation Date
    April 20, 2026
    Classification Date
    June 5, 2026
    Address
    3000 N Grandview Blvd, N/A, Waukesha, WI, 53188-1615, United States

    Description

    Allia Moveo angiographic X-ray system

    Reason

    GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.

    Code Info

    UDI-DI: 00198953052488; Serial Numbers: C4-25-001, C4-25-002, C4-26-001, C4-26-002, C4-26-004, C4-26-005

    Distribution

    Worldwide - US Nationwide distribution.

    Quantity

    3 units