INO Therapeutics (dba Ikaria): Medical Device Recall in 2014 - (Recall #: Z-0575-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product 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.

Product Classification:

Class II

Date Initiated: October 17, 2014

Date Posted: December 17, 2014

Recall Number: Z-0575-2015

Event ID: 69635

Reason for Recall:

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.

Status: Terminated

Product Quantity: 9

Code Information:

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

Distribution Pattern:

US Distribution in states of: VA and PA only.

Voluntary or Mandated:

Voluntary: Firm initiated