Recall Z-1223-2015— INO Therapeutics (dba Ikaria)
Class II · Terminated
Class II FDA medical device recall by INO Therapeutics (dba Ikaria), initiated 2015-01-14, terminated 2015-04-15. It names one FDA 510(k) clearance: K093922. Product: Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for use with ventilators.. 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
- INO Therapeutics (dba Ikaria)
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-01-14
- Terminated
- 2015-04-15
- 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
Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for use with ventilators.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.