Device recall
Z-1528-2014: INOmax DSIR, model 10007, Nitric Oxide Delivery System, with Software version…
FDA device recall · Class II · INO Therapeutics (dba Ikaria)
Key facts
| Recall number (Z-number) | Z-1528-2014 |
|---|---|
| Recall event | 67947 |
| Product | INOmax DSIR, model 10007, Nitric Oxide Delivery System, with Software version 3.0.0. The INOmax DS delivery system delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system. The primary targeted clinical… |
| Product code | MRN |
| Recalling firm | INO Therapeutics (dba Ikaria) |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 21, 2014 |
| 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