BEUDAMED
    FDA Enforcement Class II Terminated

    Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance - Product Usage: The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging.

    Recall: Z-0131-2021 · Reported October 28, 2020

    Enforcement

    Recall Number
    Z-0131-2021
    Event ID
    86452
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GE Healthcare, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 28, 2020
    Initiation Date
    September 8, 2020
    Classification Date
    October 20, 2020
    Termination Date
    April 28, 2021
    Address
    3000 N Grandview Blvd, N/A, Waukesha, WI, 53188-1615, United States

    Description

    Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance - Product Usage: The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging.

    Reason

    Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.

    Code Info

    Model: 5726207-8 and 5741000-28

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of FL, KY, NC, NJ, NM, NY, TX, UT and WA. The countries of Canada, Hungary, India, Korea, China, Russia, Taiwan, Puerto Rico and Ubekistan.

    Quantity

    N/A