Device recall
Z-1490-2020: OmniDiagnost Eleva System codes 708028 708027
FDA device recall · Class II · Philips North America, LLC
Key facts
| Recall number (Z-number) | Z-1490-2020 |
|---|---|
| Recall event | 84756 |
| Product | OmniDiagnost Eleva System codes 708028 708027 |
| Product code | OWB |
| Recalling firm | Philips North America, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 17, 2022 |
| 510(k) numbers | K032046 |
| FEI number | 1218950 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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