BEUDAMED
    FDA Enforcement Class II Ongoing

    SIGNA Premier magnetic resonance scanner, model 5748519.

    Recall: Z-1430-2022 · Reported July 27, 2022

    Enforcement

    Recall Number
    Z-1430-2022
    Event ID
    90587
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    GE Healthcare, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 27, 2022
    Initiation Date
    June 24, 2022
    Classification Date
    July 21, 2022
    Address
    3000 N Grandview Blvd, N/A, Waukesha, WI, 53188-1615, United States

    Description

    SIGNA Premier magnetic resonance scanner, model 5748519.

    Reason

    Under rare conditions, SIGNA Premier gradient coils could result in elevated acoustic noise during scanning. After prolonged periods of elevated acoustic noise, this could potentially lead to hearing loss.

    Code Info

    SIGNA Premier GTINs: 00840682135269 and 00195278010797

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of AL, AZ, CA, MI, MN, NY, and WI. There was government distribution but no military distribution. The countries of China, France, Hong Kong, India, Italy, Japan, Korea, Kuwait, Norway, Oman, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Thailand, Turkey, and United Kingdom.

    Quantity

    52