BEUDAMED
    FDA Enforcement Class II Ongoing

    Discovery MR750w 3.0T, whole body magnetic resonance scanner

    Recall: Z-0517-2025 · Reported December 4, 2024

    Enforcement

    Recall Number
    Z-0517-2025
    Event ID
    95735
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    GE Medical Systems, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 4, 2024
    Initiation Date
    October 28, 2024
    Classification Date
    November 22, 2024
    Address
    3200 N Grandview Blvd, Waukesha, WI, 53188-1693, United States

    Description

    Discovery MR750w 3.0T, whole body magnetic resonance scanner

    Reason

    Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.

    Code Info

    System ID 760724DVMR1, UDI/DI To be provided; System ID 214820TS750WMR, UDI/DI To be provided; System ID 281333MR2, UDI/DI To be provided; System ID 82427240081, UDI/DI (01)00840682103817(11)181200(21)PG75W1800047SC; System ID 82427120136, UDI/DI Not Applicable; System ID 82427200092, UDI/DI To be provided; System ID 82427250061, UDI/DI To be provided; System ID EM0232, UDI/DI Not Applicable

    Distribution

    Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of: Canada, China, India, Japan, Korea, Latvia, Mexico, Poland, Russia, Saudi Arabia, Spain, and Taiwan.

    Quantity

    8 units