BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-2477-2026 · Initiated May 1, 2026

    Recall

    Recall Number
    Z-2477-2026
    Event Number
    98986
    Firm
    GE Medical Systems, LLC
    FEI Number
    2126677
    Product Code
    FMZ
    Status
    Open, Classified
    Root Cause
    Component design/selection
    Initiated
    May 1, 2026
    Posted
    June 17, 2026
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    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.

    Action

    An URGENT MEDICAL DEVICE CORRECTION notification letter dated 5/1/26 was sent to customers. Actions to be taken by Customer/User You may continue to use your device after performing the pre-use checkout in accordance with the Giraffe OmniBed Carestation User Manual (Chapter 6 Pre-Use Checkout). During the pre-use checkout described in the product User Manual, visually inspect the device for any damaged or missing components. This includes verifying that the canopy soffit is properly secured and that all six fasteners are present and fully engaged. If you observe damage, missing fasteners, or improper soffit attachment during the pre-use checkout, please remove the device from clinical use and contact GE HealthCare Service. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. Please complete and return the attached acknowledgement form electronically via FMI 32101 Digital CRF or print, fill out manually, scan, and email to [email protected]. Please retain this document for your records. Product Correction GE HealthCare will correct all affected products at no cost to you. A GE HealthCare representative will contact you to arrange for the correction. Contact Information If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative. Please be assured that maintaining a high level of safety and quality is our highest priority. If you have any questions, please contact GE HealthCare per the contact information above.

    Distribution

    Worldwide - US Nationwide distribution.

    Quantity

    265 units