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INO Therapeutics (dba Ikaria) recalls INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0., delivers INOMAX (nitric oxide for inhala
Recalled December 17, 2014 · FDA recall Z-0575-2015 · 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. · FDA Class II
Units
9
Sold at
US Distribution in states of: VA and PA only.
Description
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.
Product
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.
Manufacturer(s)
INO Therapeutics (dba Ikaria)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →