Company:INO Therapeutics (dba Ikaria).
Date of Enforcement Report: 3/11/2015
Class lI:
PRODUCT
Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for use with ventilators. Recall Number Z-1223-2015
REASON
Potential delivery failure alarm condition. INOmax DSIR with software version 2.0.4 and a certain variant of the monitor display may trigger a delivery failure alarm when the display brightness is set to its lowest level. If this condition occurs, therapy will be interrupted..
RECALLING FIRM/MANUFACTURER
INO Therapeutics (dba Ikaria), Madison, WI on 1/14/2015 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
45 units.
DISTRIBUTION
Nationwide
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