Ikaria — Class II medical device recall Z-1223-2015
Terminated recall by INO Therapeutics (dba Ikaria), reported 2015-03-11, distributed nationwide. Potential delivery failure alarm condition. INOmax DSIR with software version 2.0.4 and a certain variant of t
| Recall number | Z-1223-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | INO Therapeutics (dba Ikaria), Madison, WI, United States |
| Recall initiated | 2015-01-14 |
| Classified | 2015-02-27 |
| Reported by FDA | 2015-03-11 |
| Terminated | 2015-04-15 |
| Distributed | Nationwide (US) |
| Quantity | 45 units |
| Reason classes | software |
| Serial numbers | DS20070005, DS20070010, DS20070041, DS20070101, DS20070255, DS20080024, DS20080064, DS20080074, DS20080141, DS20080222, DS20080229, DS20080298, DS20080314, DS20080318, DS20090013, DS20090028, DS20090034, DS20090052, DS20090086, DS20090109, DS20090121, DS20090190, DS20090265, DS20090328, DS20090424 and 100 more |
| Model numbers | 10007 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1223-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.