Device recall
Z-0770-2020: The PLEX Elite 9000, a Swept-Source OCT [SS-OCT] - Product Usage: The PLEX Elite…
FDA device recall · Class II · Carl Zeiss Meditec, Inc.
Key facts
| Recall number (Z-number) | Z-0770-2020 |
|---|---|
| Recall event | 83229 |
| Product | The PLEX Elite 9000, a Swept-Source OCT [SS-OCT] - Product Usage: The PLEX Elite 9000 Swept-Source OCT [SS-OCT] is a non- contact, high resolution, wide field of view tomographic and biomicroscopic imaging device intended for in-vivo viewing, axial cross-sectional and three-dimensional imaging of… |
| Product code | OBO |
| Recalling firm | Carl Zeiss Meditec, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 11, 2021 |
| 510(k) numbers | K161194 |
| FEI number | 2918630 |
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