BEUDAMED
    FDA Enforcement Class II Terminated

    INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0., delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and comprehensive alarm systems. The primary clinical settings are Neonatal Intensive Care Units (NICU) and to transport of neonates.

    Recall: Z-0575-2015 · Reported December 17, 2014

    Enforcement

    Recall Number
    Z-0575-2015
    Event ID
    69635
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    INO Therapeutics (dba Ikaria)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    December 17, 2014
    Initiation Date
    October 17, 2014
    Classification Date
    December 9, 2014
    Termination Date
    April 16, 2015
    Address
    2902 Dairy Dr, N/A, Madison, WI, 53718-3809, United States

    Description

    INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0., delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and comprehensive alarm systems. The primary clinical settings are Neonatal Intensive Care Units (NICU) and to transport of neonates.

    Reason

    An issue has been identified in the INOmax DSIR system that could result in monitored Nitric Oxide (NO) concentration reporting lower than expected. This issue only pertains to those devices manufactured using a specific version of the Monitoring Circuit Board.

    Code Info

    Serial Numbers: DS20080152, DS20090925, DS20101076, DS20101499, DS20110886, DS20110965, DS20120099, DS20120150, DS20120169.

    Distribution

    US Distribution in states of: VA and PA only.

    Quantity

    9