Ikaria INOmax DSIR Nitric Oxide Delivery System Recalled for Alarm Defect
INO Therapeutics is recalling 45 INOmax DSIR units because a specific software and display combination may trigger false alarms, interrupting nitric oxide therapy.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves the interruption of medical therapy (nitric oxide delivery) due to a false alarm, which poses a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
INO Therapeutics (dba Ikaria) is recalling 45 units of the INOmax DSIR (Delivery System), Model 10007. This nitric oxide delivery system is designed for use with ventilators. The recall is due to a potential delivery failure alarm condition.
The issue occurs when the device is equipped with software version 2.0.4 and a specific variant of the monitor display. If the display brightness is set to its lowest level, the system may trigger a delivery failure alarm. When this condition occurs, the nitric oxide therapy is interrupted.
The affected units were distributed nationwide in the United States, including in Arizona, California, Connecticut, Florida, Idaho, Louisiana, Maryland, Michigan, Mississippi, New Hampshire, New Jersey, Nevada, New York, Oklahoma, Pennsylvania, Texas, Utah, Virginia, and West Virginia. Users should check their device serial numbers against the list provided by the manufacturer and contact INO Therapeutics for instructions on how to resolve the issue.
The recalled product
- Product
- Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for use with ventilators.
- Manufacturer
- INO Therapeutics (dba Ikaria)
- Affected units
- 45
Distribution
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