Device recall
Z-0622-2022: bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e…
FDA device recall · Class I · Vyaire Medical
Key facts
| Recall number (Z-number) | Z-0622-2022 |
|---|---|
| Recall event | 89366 |
| Product | bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventilator, 301.100.130. The bellavista 1000/1000e ventilator is intended to provide positive pressure ventilatory support to adult and pediatric patients, and optionally, infant and neonatal patients. |
| Product code | CBK |
| Recalling firm | Vyaire Medical |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Aug 28, 2024 |
| 510(k) numbers | K183364 |
| FEI number | 2050001 |
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