Devices

Device Recall INOmax DSIR Delivery System

  • Modelo / Serial
    Serial Numbers: DS20080152, DS20090218, DS20090243, DS20090271, DS20090523, DS20090598, DS20090821, DS20090925, DS20101022, DS20101076, DS20101147, DS20101374, DS20101413, DS20101420,  DS20101499, DS20101637, DS20111199, DS20120099, DS20120150, DS20120169, DS20120288, DS20120306.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including DC and VA.
  • Descripción del producto
    INOmax DSIR, model 10007, Nitric Oxide Delivery System, with Software version 3.0.0. The INOmax DS delivery system delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates.
  • Manufacturer
    INO Therapeutics (dba Ikaria)
  • 1 Event

Fabricante

INO Therapeutics (dba Ikaria)
  • Dirección del fabricante
    INO Therapeutics (dba Ikaria), 2902 Dairy Dr, Madison WI 53718-3809
  • Empresa matriz del fabricante (2017)
    Mallinckrodt Plc
  • Source
    USFDA