Device recall
Z-1143-2014: Trilogy Ventilators The Respironics Trilogy 100 system provides continuous or…
FDA device recall · Class I · Phillips Respironics, Inc.
Key facts
| Recall number (Z-number) | Z-1143-2014 |
|---|---|
| Recall event | 67550 |
| Product | Trilogy Ventilators The Respironics Trilogy 100 system provides continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation. Trilogy 100 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The device is intended to be… |
| Product code | CBK |
| Recalling firm | Phillips Respironics, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Apr 17, 2015 |
| 510(k) numbers | K083526, K093416, K093905 |
| 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