Device recall
Z-1617-2010: Newport e360 Ventilator The e360 Ventilator System is intended to provide…
FDA device recall · Class II · Newport Medical Instruments Inc
Key facts
| Recall number (Z-number) | Z-1617-2010 |
|---|---|
| Recall event | 55504 |
| Product | Newport e360 Ventilator The e360 Ventilator System is intended to provide continuous (endotracheal or tracheostomy [ET] tube) or non-continuous (mask) ventilatory support and monitoring for infant, pediatric, and adult patients requiring tidal volumes equal to or greater than 20 milliliters (mL)… |
| Product code | CBK |
| Recalling firm | Newport Medical Instruments Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 18, 2011 |
| 510(k) numbers | K053502 |
| FEI number | 2023050 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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