Device recall
Z-1382-2022: Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory…
FDA device recall · Class II · Breas Medical, Inc.
Key facts
| Recall number (Z-number) | Z-1382-2022 |
|---|---|
| Recall event | 90433 |
| Product | Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation Model Number: 230000 If the recalled product is a software, include version number: firmware versions 5.0.5 or earlier |
| Product code | NOU |
| Recalling firm | Breas Medical, Inc. |
| Recall class | Class II |
| 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