Dec

2014

Cl II INOMAX DSIR Nitric Oxide delivery system

Company: INO Therapeutics (dba Ikaria).
Date of Enforcement Report 12/17/2014
Class lI:

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.
Recall Number Z-0575-2015

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..

RECALLING FIRM/MANUFACTURER
INO Therapeutics (dba Ikaria), Madison WI 10/17/2014. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
9

DISTRIBUTION
US Distribution in states of: VA and PA only.

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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl II INOMAX DSIR Nitric Oxide delivery system

Amy Sellers

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