BEUDAMED
    FDA Enforcement Class I Ongoing

    EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002

    Recall: Z-0775-2024 · Reported February 7, 2024

    Enforcement

    Recall Number
    Z-0775-2024
    Event ID
    93715
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Datex-Ohmeda, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 7, 2024
    Initiation Date
    December 29, 2023
    Classification Date
    January 30, 2024
    Address
    3030 Ohmeda Dr, Madison, WI, 53718-6704, United States

    Description

    EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002

    Reason

    GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air) optional compressors are used with the CARESCAPE R860 or Engstr¿m Carestation/Pro ventilators, respectively. These elevated results were observed in preliminary testing that was conducted at an elevated room temperature of 40oC (104oF), at the lowest possible flow condition of 2 L/min (worstcase, minimum bias flow with no additional ventilation), and all of the gas being supplied from the compressor (i.e., FiO2 of 21% / no supplemental oxygen). GE HealthCare is continuing to evaluate the root cause for these elevated levels of formaldehyde. While these test conditions are not representative of typical clinical use conditions,GE HealthCare is taking this action to further reduce the potential for patient exposure.

    Code Info

    UDI/DI ********, Serial Numbers: CBCS01269, CBCT02328, CBCT03050, CBCT02306, CBCT02301, CBCT02303, CBCT02302, CBCT02088, CBCT02309, CBCT02304, CBCU00717, CBCU00559

    Distribution

    Worldwide

    Quantity

    12 units