Device recall
Z-0838-2019: PROVEO 8 Ophthalmic Microscope System optical instrument for improving the…
FDA device recall · Class II · Leica Microsystems, Inc.
Key facts
| Recall number (Z-number) | Z-0838-2019 |
|---|---|
| Recall event | 78190 |
| Product | PROVEO 8 Ophthalmic Microscope System optical instrument for improving the visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment. |
| Product code | HRM |
| Recalling firm | Leica Microsystems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 21, 2020 |
| FEI number | 3000210133 |
At a glance
- None 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