Device recall
Z-2530-2018: Vivo 65, Continuous Ventilator, Home Use, Cat. No. 204000 Product Usage: To…
FDA device recall · Class III · Human Design Medical Llc
Key facts
| Recall number (Z-number) | Z-2530-2018 |
|---|---|
| Recall event | 80296 |
| Product | Vivo 65, Continuous Ventilator, Home Use, Cat. No. 204000 Product Usage: To provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation |
| Product code | NOU |
| Recalling firm | Human Design Medical Llc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 4, 2020 |
| 510(k) numbers | K160481 |
| 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