BEUDAMED
    FDA Enforcement Class I Ongoing

    GE Healthcare neonatal incubator, models: a) Lullaby Incubator, b) Lullaby Incubator XP, c) Lullaby Incubator TR

    Recall: Z-0958-2024 · Reported February 21, 2024

    Enforcement

    Recall Number
    Z-0958-2024
    Event ID
    93780
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Wipro GE Healthcare Private Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 21, 2024
    Initiation Date
    December 26, 2023
    Classification Date
    February 9, 2024
    Address
    122 Part 1, Odyssey And Galileo, Bengaluru, N/A, N/A, India

    Description

    GE Healthcare neonatal incubator, models: a) Lullaby Incubator, b) Lullaby Incubator XP, c) Lullaby Incubator TR

    Reason

    GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, 3000 and 4000 Incubator, Lullaby Incubator, Lullaby TR Incubator, and Lullaby XP Incubator can be upright and look closed but not be latched if the red indicator is visible. The portholes also can look closed when not latched when the portholes are obstructed e.g., hood covers. If a patient impacts the bedside panel or porthole that is not latched, the panel can disengage and fall open, no longer protecting the patient from falling.

    Code Info

    a) Lullaby Incubator, Model Numbers: M1151042, QCR031; b) Lullaby Incubator XP, Model Numbers: 8320, M1151135, QCR034; c) Lullaby Incubator TR, Model Numbers: M1151357 ALL SERIAL NUMBERS

    Distribution

    Worldwide distribution.

    Quantity

    1410 units