FDA-Device2014-12-17Class II
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.
INO Therapeutics (dba Ikaria)
Hazard
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.
Sold states
US Distribution in states of: VA and PA only.
Affected count
9
Manufactured in
2902 Dairy Dr, N/A, Madison, WI, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0575-2015Don't want to check this manually?
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