BEUDAMED
    FDA Enforcement Class I Ongoing

    GE Heathcare Giraffe OmniBed; neo natal incubator

    Recall: Z-0047-2025 · Reported October 23, 2024

    Enforcement

    Recall Number
    Z-0047-2025
    Event ID
    95282
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    DATEX--OHMEDA, INC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 23, 2024
    Initiation Date
    September 3, 2024
    Classification Date
    October 17, 2024
    Address
    9900 W Innovation Dr, Wauwatosa, WI, 53226-4856, United States

    Description

    GE Heathcare Giraffe OmniBed; neo natal incubator

    Reason

    GE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices, the screw that secures the doors that cover the warmer heaters may not have been torqued to specification. This may lead to the doors becoming loose.

    Code Info

    All models

    Distribution

    Worldwide distribution.