Device recall
Z-1287-2023: Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventilator, Model Numbers…
FDA device recall · Class I · Philips Respironics, Inc.
Key facts
| Recall number (Z-number) | Z-1287-2023 |
|---|---|
| Recall event | 91832 |
| Product | Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventilator, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, JP2100X16B, AU2100X15B, LA2100X15B, CA2100X12B, CN2100X17B, BR2100X18B, KR2100X15B, IA2100X15B, PP2100X10, FP2100X10, FR2100X14B, ND2100X15B, IT2100X21B, ES2100X15B, DE2100X13B… |
| Product code | CBK |
| Recalling firm | Philips Respironics, Inc. |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K181166 |
| 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