Device recall
Z-0951-2020: Trilogy EVO Ventilator, 02 - Italy - Model Number: IT2100X21B Trilogy Evo is…
FDA device recall · Class I · Philips Respironics, Inc.
Key facts
| Recall number (Z-number) | Z-0951-2020 |
|---|---|
| Recall event | 84406 |
| Product | Trilogy EVO Ventilator, 02 - Italy - Model Number: IT2100X21B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories. |
| Product code | CBK |
| Recalling firm | Philips Respironics, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Mar 31, 2021 |
| 510(k) numbers | K181166 |
| FEI number | 2518422 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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