FDAFDA · Food and drugs·Recall number Z-0575-2015
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.
Published December 17, 2014 · Recall initiated: October 17, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- INO Therapeutics (dba Ikaria)
- Distributor
- US Distribution in states of: VA and PA only.
- Lot
- Serial Numbers: DS20080152, DS20090925, DS20101076, DS20101499, DS20110886, DS20110965, DS20120099, DS20120150, DS20120169.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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