Recall Z-1528-2014— INO Therapeutics (dba Ikaria)

Name: FDA recall Z-1528-2014
Creator: U.S. Food and Drug Administration
Published: 2014-03-27

Class II · Terminated

Class II FDA medical device recall by INO Therapeutics (dba Ikaria), initiated 2014-03-27, terminated 2014-11-21. It names one FDA 510(k) clearance: K131686. Product: INOmax DSIR, model 10007, Nitric Oxide Delivery System, with Software version 3.0.0. The INOmax DS delivery system delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates.. Reason: An anomaly impacts the monitoring system of INOmax DSIR Plus (software 3.0.0). When the integrated pneumatic backup switch is activated with low or no gas flow through the injector module, an intended NO cell failure alarm will occur. In addition, an unintended NO2 cell failure alarm may also occur. The NO/NO2 cell failure alarms are caused by an average NO/NO2 circuit concentration greater tha.

Recalling firm: INO Therapeutics (dba Ikaria)
Classification: Class II
Status: Terminated
Initiated: 2014-03-27
Terminated: 2014-11-21
Firm location: Madison, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K131686 — INOMAX DSIR (DELIVERY SYSTEM)Ino Therapeutics/Ikaria·cleared 2013-11-29

K-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, model 10007, Nitric Oxide Delivery System, with Software version 3.0.0. The INOmax DS delivery system delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates.

Reason for recall

An anomaly impacts the monitoring system of INOmax DSIR Plus (software 3.0.0). When the integrated pneumatic backup switch is activated with low or no gas flow through the injector module, an intended NO cell failure alarm will occur. In addition, an unintended NO2 cell failure alarm may also occur. The NO/NO2 cell failure alarms are caused by an average NO/NO2 circuit concentration greater tha

Data sourced from openFDA. This site is unofficial and independent of the FDA.