Mar

2015

INOmax DSIR, Cl II Ikaria

Company:INO Therapeutics (dba Ikaria).
Date of Enforcement Report: 3/11/2015
Class lI:

PRODUCT

Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for use with ventilators. Recall Number Z-1223-2015

REASON
Potential delivery failure alarm condition. INOmax DSIR with software version 2.0.4 and a certain variant of the monitor display may trigger a delivery failure alarm when the display brightness is set to its lowest level. If this condition occurs, therapy will be interrupted..

RECALLING FIRM/MANUFACTURER
INO Therapeutics (dba Ikaria), Madison, WI on 1/14/2015 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
45 units.

DISTRIBUTION
Nationwide

___________________________________

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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INOmax DSIR, Cl II Ikaria

Amy Sellers

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