Device recall
Z-2344-2008: PLV-100 Portable Lifecare Ventilator Life support ventilation The device is…
FDA device recall · Class II · Respironics, Inc.
Key facts
| Recall number (Z-number) | Z-2344-2008 |
|---|---|
| Recall event | 48980 |
| Product | PLV-100 Portable Lifecare Ventilator Life support ventilation The device is intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Life support ventilation |
| Product code | CBK |
| Recalling firm | Respironics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 23, 2009 |
| 510(k) numbers | K832467 |
| FEI number | 2518422 |
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