Device recall
Z-0597-2020: EasyOne Pro LAB VOS Respiratory Analysis System Pulmonary Function Testing…
FDA device recall · Class II · NDDd Medical Technologies, Inc.
Key facts
| Recall number (Z-number) | Z-0597-2020 |
|---|---|
| Recall event | 83992 |
| Product | EasyOne Pro LAB VOS Respiratory Analysis System Pulmonary Function Testing Device, Model 3100-1 |
| Product code | BTY |
| Recalling firm | NDDd Medical Technologies, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 5, 2020 |
| 510(k) numbers | K161534 |
| FEI number | 3002918917 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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