Device recall
Z-1056-2019: URODiagnost Eleva, Product codes 708026, 708027, 708028 Product Usage: The…
FDA device recall · Class II · Philips North America, LLC
Key facts
| Recall number (Z-number) | Z-1056-2019 |
|---|---|
| Recall event | 82313 |
| Product | URODiagnost Eleva, Product codes 708026, 708027, 708028 Product Usage: The Philips OmniDiagnost is a multi-functional, universal X-ray system with remote-controlled facilities. It performs a wide range of routine examinations and interventional procedures include: Gastro-intestinal examination… |
| Product code | OWB |
| Recalling firm | Philips North America, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 3, 2020 |
| 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