Device recall
Z-1606-2009: Respironics BiPAP Focus Noninvasive Ventilator System. The BiPAP Focus is a…
FDA device recall · Class I · Respironics California Inc
Key facts
| Recall number (Z-number) | Z-1606-2009 |
|---|---|
| Recall event | 52016 |
| Product | Respironics BiPAP Focus Noninvasive Ventilator System. The BiPAP Focus is a non-invasive, pressure support ventilator used to augment the breathing of patients suffering from acute or chronic respiratory insufficiency, respiratory failure or to maintain airway patency and provide respiratory support… |
| Product code | MNS |
| Recalling firm | Respironics California Inc |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jul 6, 2010 |
| 510(k) numbers | K053168 |
| FEI number | 2518422 |
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