Device recall
Z-0575-2015: INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0…
FDA device recall · Class II · INO Therapeutics (dba Ikaria)
Key facts
| Recall number (Z-number) | Z-0575-2015 |
|---|---|
| Recall event | 69635 |
| Product | INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0., delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and comprehensive alarm systems. The primary clinical settings are Neonatal Intensive Care Units… |
| Product code | MRN |
| Recalling firm | INO Therapeutics (dba Ikaria) |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 16, 2015 |
| 510(k) numbers | K131686 |
| FEI number | 3004531588 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database