BEUDAMED
    FDA Enforcement Class II Ongoing

    GE SIGNA Artist Evo, Nuclear Magnetic Resonance Imaging System

    Recall: Z-2310-2025 · Reported August 20, 2025

    Enforcement

    Recall Number
    Z-2310-2025
    Event ID
    97187
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    GE Medical Systems, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 20, 2025
    Initiation Date
    June 20, 2025
    Classification Date
    August 13, 2025
    Address
    3200 N Grandview Blvd, N/A, Waukesha, WI, 53188-1693, United States

    Description

    GE SIGNA Artist Evo, Nuclear Magnetic Resonance Imaging System

    Reason

    GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.

    Code Info

    GTIN 00195278481382, 00840682118118, 00840682123129, 00840682147095, Not Applicable, GTIN Not Available; All System ID numbers that GE HealthCare performed planned maintenance on since March 1, 2023

    Distribution

    Worldwide distribution.

    Quantity

    138 units