BEUDAMED
    FDA Enforcement Class II Terminated

    Kappa, Catalog Number: MS18853 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus. Catalog Number(s): MS18597/MS18596/MS18853. Product Usage: The devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patients medical condition. The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended to be used on adult, pediatric, and neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, and arrhythmia which are intended for use in the adult and pediatric populations only; and tcpO2, which for the neonatal population, is to only be used when the patient is not under gas anesthesia. For combination with Scio gas module: Scio gas module samples breathing gases from adults and pediatrics. The gas module continuously measure the content of CO2, N2O, O2 and one of the anesthetic agents, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane in any mixture and communicates real time and derived gas information to the In-finity monitors.

    Recall: Z-1774-2017 · Reported April 19, 2017

    Enforcement

    Recall Number
    Z-1774-2017
    Event ID
    76862
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Draegar Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 19, 2017
    Initiation Date
    March 28, 2017
    Classification Date
    April 10, 2017
    Termination Date
    September 17, 2018
    Address
    6 Tech Dr, N/A, Andover, MA, 01810-2434, United States

    Description

    Kappa, Catalog Number: MS18853 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus. Catalog Number(s): MS18597/MS18596/MS18853. Product Usage: The devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patients medical condition. The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended to be used on adult, pediatric, and neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, and arrhythmia which are intended for use in the adult and pediatric populations only; and tcpO2, which for the neonatal population, is to only be used when the patient is not under gas anesthesia. For combination with Scio gas module: Scio gas module samples breathing gases from adults and pediatrics. The gas module continuously measure the content of CO2, N2O, O2 and one of the anesthetic agents, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane in any mixture and communicates real time and derived gas information to the In-finity monitors.

    Reason

    It was reported that a set low O2 alarm does not go off although the measured O2 level is below the alarm limit.

    Code Info

    VF10.0 software

    Distribution

    Worldwide - US Nationwide distribution in the states of: AL, CA, GA, IL, LA, MA NY, OH, PA, TN, TX and VA and the countries of: AR AT BE BG BN BO BY CA CH CL CO CZ DE EG ES FI FR GB GR HR HU ID IE IL IN IT LT MX MY NL NO NP PA PE PK PL PT RO RS RU SA SE SK TH TR TW UG UZ VN ZA

    Quantity

    2,156 (total for all devices)