BEUDAMED
    FDA Enforcement Class I Terminated

    Giraffe OmniBed Carestation, Model Numbers: 2082844-001-XXXXXX; Giraffe OmniBed Carestation CS1, Model Numbers: 2082844-001-XXXXXXXX. infant warmer

    Recall: Z-0539-2020 · Reported December 11, 2019

    Enforcement

    Recall Number
    Z-0539-2020
    Event ID
    84077
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    GE Healthcare, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 11, 2019
    Initiation Date
    October 11, 2019
    Classification Date
    December 3, 2019
    Termination Date
    August 15, 2024
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615, United States

    Description

    Giraffe OmniBed Carestation, Model Numbers: 2082844-001-XXXXXX; Giraffe OmniBed Carestation CS1, Model Numbers: 2082844-001-XXXXXXXX. infant warmer

    Reason

    Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear closed without being latched. Potential patient fall.

    Code Info

    Giraffe OmniBed Carestation, Model Numbers: 2082844-001-XXXXXX Giraffe OmniBed Carestation CS1, Model Numbers: 2082844-001-XXXXXXXX Updated 6/3/2021 - All model numbers and units are affected.

    Distribution

    worldwide

    Quantity

    7814 units