Device recall
Z-1439-2020: bellavista 1000 ventilator, Catalog number 301.100.030. bellavista is an…
FDA device recall · Class II · Vyaire Medical
Key facts
| Recall number (Z-number) | Z-1439-2020 |
|---|---|
| Recall event | 84337 |
| Product | bellavista 1000 ventilator, Catalog number 301.100.030. bellavista is an electronically controlled pneumatic ventilation system with an integrated air compressing system. bellavista uses room air and high-pressure oxygen. Air enters through a fresh gas intake port and is compressed together with the… |
| Product code | CBK |
| Recalling firm | Vyaire Medical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 8, 2023 |
| 510(k) numbers | K163127 |
| 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