Device recall
Z-1577-2014: Recalled product is a component of the Newport Medical Instruments e360…
FDA device recall · Class II · Nellcor Puritan Bennett Inc. (dba Covidien LP)
Key facts
| Recall number (Z-number) | Z-1577-2014 |
|---|---|
| Recall event | 68099 |
| Product | Recalled product is a component of the Newport Medical Instruments e360 Ventilator: single board computer, part number SBC2105A. Intended to provide invasive or noninvasive ventilator support and monitoring for infant, pediatric, and adult patients with respiratory failure or respiratory… |
| Product code | CBK |
| Recalling firm | Nellcor Puritan Bennett Inc. (dba Covidien LP) |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 1, 2016 |
| FEI number | 2936999 |
At a glance
- None 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