FDA-Device2015-03-11Class II
Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for use with ventilators.
INO Therapeutics (dba Ikaria)
Hazard
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.
Sold states
Distribution US nationwide, including AZ, CA, CT, FL, ID, LA, MD, MI, MS, NH, NJ, NV, NY, OK, PA, TX, UT, VA, WV.
Affected count
45 units
Manufactured in
2902 Dairy Dr, N/A, Madison, WI, United States
Products
Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for use with ventilators.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1223-2015Don't want to check this manually?
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