BEUDAMED
    FDA Enforcement Class I Ongoing

    Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 6677300 Flow-i C40, Part no. 6677400

    Recall: Z-0959-2023 · Reported February 1, 2023

    Enforcement

    Recall Number
    Z-0959-2023
    Event ID
    91339
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Getinge Usa Sales Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 1, 2023
    Initiation Date
    December 22, 2022
    Classification Date
    January 26, 2023
    Address
    1 Geoffrey Way, N/A, Wayne, NJ, 07470-2035, United States

    Description

    Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 6677300 Flow-i C40, Part no. 6677400

    Reason

    Due to a software bug, under certain conditions, pressure cannot be built up resulting in no ventilation. If gas delivery is stopped, a sustained decrease in delivered O2 concentration may lead to hypoventilation and hypoxia.

    Code Info

    Part # UDI 6677200 7325710001349 Serial Numbers 1202-8027 Part # UDI 6677300 7325710001363 Serial Numbers 1058-1201 Part # UDI 6677400 7325710001318 Serial Numbers 2034-8446 Software versions 4.8.0, 4.8.1, 4.8.2, and 4.8.3.

    Distribution

    US nationwide and Worldwide Distribution: Domestic distribution to AL, AR, AZ, CA, CO, DC, FL, GA, IN, MA, MI, MO, NY, OH, OR, PA, TX, VA, WA, WV. Foreign distribution worldwide.

    Quantity

    8,016 Total (7,766 OUS; 250 US)