INOmax DSIR Nitric Oxide System Recalled for Monitoring Error
INO Therapeutics is recalling nine INOmax DSIR Nitric Oxide delivery systems because they may report lower-than-expected NO concentrations.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device used in neonatal care where a monitoring error could lead to incorrect therapy administration, representing a risk of harm without reported injuries.
Plain-English summary
INO Therapeutics (dba Ikaria) is recalling nine INOmax DSIR Nitric Oxide delivery systems, Model 10007, software version 3.1.0. The recall affects devices manufactured using a specific version of the Monitoring Circuit Board.
The recall is due to an issue that could result in monitored Nitric Oxide (NO) concentration reporting lower than expected. The affected devices are used primarily in Neonatal Intensive Care Units (NICU) and for the transport of neonates.
The affected units were distributed in Virginia and Pennsylvania. The specific serial numbers for the recalled devices are DS20080152, DS20090925, DS20101076, DS20101499, DS20110886, DS20110965, DS20120099, DS20120150, and DS20120169.
The recalled product
- 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…
- Manufacturer
- INO Therapeutics (dba Ikaria)
- Hazard
- Affected units
- 9
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Serial Numbers: DS20080152
- DS20090925
- DS20101076
- DS20101499
- DS20110886
- DS20110965
- DS20120099
- DS20120150
- DS20120169.
Distribution
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