BEUDAMED
    FDA Recall 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 · Initiated October 17, 2014

    Recall

    Recall Number
    Z-0575-2015
    Event Number
    69635
    Firm
    INO Therapeutics (dba Ikaria)
    FEI Number
    3004531588
    Product Code
    MRN
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    October 17, 2014
    Posted
    December 12, 2014
    Terminated
    April 16, 2015
    Address
    2902 Dairy Dr, Madison, WI, 53718-3809

    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.

    Action

    Ikaria contacted consignees by phone beginning 10/17/2014. A follow-up letter was sent to customers beginning 10/22/2014. The letter described the issue, requested that affected devices not be used and to return to Ikaria. Customers with questions can contact Ikaria Customer Care at 1-877-566-9466.

    Distribution

    US Distribution in states of: VA and PA only.

    Quantity

    9