BEUDAMED
    FDA Enforcement Class II Ongoing

    Beside panel FRU (Field Replacement Units) Kits

    Recall: Z-2102-2023 · Reported July 12, 2023

    Enforcement

    Recall Number
    Z-2102-2023
    Event ID
    92454
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    DATEX--OHMEDA, INC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 12, 2023
    Initiation Date
    May 19, 2023
    Classification Date
    July 6, 2023
    Address
    9900 W Innovation Dr, N/A, Wauwatosa, WI, 53226-4856, United States

    Description

    Beside panel FRU (Field Replacement Units) Kits

    Reason

    GE HealthCare has become aware of the potential that an incorrect type of secondary latch could have been installed on the northeast (NE) and/or northwest (NW) bedside panels for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices

    Code Info

    Models: 5865384-01 to 5865384-34, 5865385-01 to 5865385-34, 5865386-01 to 5865386-34 and 5865387-01 to 5865387-34

    Distribution

    Worldwide distribution.

    Quantity

    18