Recall Z-0575-2015— INO Therapeutics (dba Ikaria)
Class II · Terminated
Class II FDA medical device recall by INO Therapeutics (dba Ikaria), initiated 2014-10-17, terminated 2015-04-16. It names one FDA 510(k) clearance: K131686. 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.. 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
- INO Therapeutics (dba Ikaria)
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-10-17
- Terminated
- 2015-04-16
- Firm location
- Madison, WI, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.