BEUDAMED
    FDA Enforcement Class II Terminated

    SIGNA Voyager nuclear magnetic resonance imaging system

    Recall: Z-0138-2022 · Reported October 27, 2021

    Enforcement

    Recall Number
    Z-0138-2022
    Event ID
    88665
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GE Healthcare, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 27, 2021
    Initiation Date
    August 26, 2021
    Classification Date
    October 16, 2021
    Termination Date
    May 4, 2026
    Address
    3000 N Grandview Blvd, N/A, Waukesha, WI, 53188-1615, United States

    Description

    SIGNA Voyager nuclear magnetic resonance imaging system

    Reason

    Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

    Code Info

    Software version VX29.1; and PX26.4 (China only)

    Distribution

    Distribution in United States to AZ, CA, FL, GA, IL, LA, MA, MD, MN, NC, NH, NJ, NY, OH, OK, TX, VA, WA, and Puerto Rico OUS distribution to: Australia, Belgium, Canada, Chile, Colombia, France, Germany, Italy, Japan, Korea, Poland, Saudi Arabia, Spain, Sweden, Turkey, UAE, and UK

    Quantity

    15 devices