BEUDAMED
    FDA Enforcement Class II Ongoing

    GE Healthcare Innova IGS 5, computed tomography x-ray system

    Recall: Z-1777-2024 · Reported May 15, 2024

    Enforcement

    Recall Number
    Z-1777-2024
    Event ID
    94305
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    GE Medical Systems, SCS
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 15, 2024
    Initiation Date
    March 18, 2024
    Classification Date
    May 6, 2024
    Address
    283 rue de la Miniere, N/A, Buc, N/A, N/A, France

    Description

    GE Healthcare Innova IGS 5, computed tomography x-ray system

    Reason

    GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fall of the Detector/Elevator or X-ray tube of the frontal Gantry assembly.

    Code Info

    UDI/DI 00840682124621, Serial Numbers: M2-23-042, M2-23-046, M2-23-048, M2-23-051, M2-24-001, M3-23-097, M3-23-098, M3-23-106, M3-23-108, M3-23-109, M3-23-111, M3-23-112, M3-23-114, M3-23-116, M3-23-123, M4-23-046, M4-23-053, M4-23-054, M4-23-055, M4-23-056, M4-24-001

    Distribution

    Worldwide distribution - US Nationwide in the states of CA, FL, GA, IN, MA, NC, OK, SC, TN, TX, VA and the countries of Armenia, China, France, Hungary, India, Italy, Japan, Kazakhstan, Lithuania, Mexico, Russia, Spain, Taiwan, Turkey, Vietnam

    Quantity

    21 units