BEUDAMED
    FDA Recall Open, Classified

    GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal incubator

    Recall: Z-0048-2025 · Initiated September 3, 2024

    Recall

    Recall Number
    Z-0048-2025
    Event Number
    95282
    Firm
    DATEX--OHMEDA, INC.
    FEI Number
    3014220748
    Product Code
    FMZ
    Status
    Open, Classified
    Root Cause
    Use error
    Initiated
    September 3, 2024
    Posted
    October 17, 2024
    Address
    9900 W Innovation Dr, Wauwatosa, WI, 53226-4856

    Description

    GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; 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.

    Action

    GE HealthCare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 09/03/2024 via Fed-Ex. The notice explained the problem with the device, safety issue, and requested the following: Download the Service Manual Addendum (5971733) from the GE HealthCare Customer Documentation Portal: https://www.gehealthcare.com/support/manuals. Inspect the heater door mounting screw on your device. If the screw is not appropriately tightened, complete steps 9 and 10 of Section 1.1 of the Service Manual Addendum (5971733).

    Distribution

    Worldwide distribution.