BEUDAMED
    FDA Enforcement Class II Ongoing

    Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500

    Recall: Z-2477-2026 · Reported June 24, 2026

    Enforcement

    Recall Number
    Z-2477-2026
    Event ID
    98986
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    GE Medical Systems, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 24, 2026
    Initiation Date
    May 1, 2026
    Classification Date
    June 17, 2026
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615, United States

    Description

    Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500

    Reason

    GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during transport, one or more of the fasteners that secure the soffit can disengage. If this occurs, a fastener could fall into the patient compartment. In rare circumstances, if multiple fasteners disengage, the canopy soffit can become loose or detach. These conditions could potentially result in patient injury.

    Code Info

    Serial Numbers: 5452896 801057486 800977619 801093759 5584569 5587625 5367527 5603110 5371240 5497382

    Distribution

    Worldwide - US Nationwide distribution.

    Quantity

    265 units