Home / Recalls / Medical Devices
INO Therapeutics (dba Ikaria) recalls Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for use with ventilators.
Recalled March 11, 2015 · FDA recall Z-1223-2015 · 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. · FDA Class II
Units
45 units
Sold at
Distribution US nationwide, including AZ, CA, CT, FL, ID, LA, MD, MI, MS, NH, NJ, NV, NY, OK, PA, TX, UT, VA, WV.
Description
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.
Product
Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for use with ventilators.
Manufacturer(s)
INO Therapeutics (dba Ikaria)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →