Device recall
Z-2690-2024: Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or…
FDA device recall · Class I · Breas Medical, Inc.
Key facts
| Recall number (Z-number) | Z-2690-2024 |
|---|---|
| Recall event | 95042 |
| Product | Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for patients who require invasive or non-invasive mechanical ventilation, Model/Catalog Number: 230000 (230016, 230216) |
| Product code | NOU |
| Recalling firm | Breas Medical, Inc. |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K193586 |
| FEI number | 3010817335 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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