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.
FDA Recall Z-0575-2015 · Posted 2014-12-12
Recalling FirmINO Therapeutics (dba Ikaria)
Recall StatusTerminated
Product CodeMRN
Date Initiated2014-10-17
Date Terminated2015-04-16
Product Quantity9
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.
Firm Action
Ikaria contacted consignees by phone beginning 10/17/2014.
A follow-up letter was sent to customers beginning 10/22/2014. The letter described the issue, requested that affected devices not be used and to return to Ikaria. Customers with questions can contact Ikaria Customer Care at 1-877-566-9466.
Root Cause
Process change control
Distribution Pattern
US Distribution in states of: VA and PA only.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.