Device recall
Z-0977-2019: e600 Automatic Transport Ventilator, Model Number 01EVE600
FDA device recall · Class I · O-Two Medical Technologies, Inc.
Key facts
| Recall number (Z-number) | Z-0977-2019 |
|---|---|
| Recall event | 82178 |
| Product | e600 Automatic Transport Ventilator, Model Number 01EVE600 |
| Product code | BTL |
| Recalling firm | O-Two Medical Technologies, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jun 29, 2023 |
| 510(k) numbers | K141595 |
| FEI number | 3002807836 |
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