Device recall
Z-1499-2016: Leica Microsystems (Schweiz) Ag. The common name of the device is surgical…
FDA device recall · Class II · Leica Microsystems, Inc.
Key facts
| Recall number (Z-number) | Z-1499-2016 |
|---|---|
| Recall event | 73557 |
| Product | Leica Microsystems (Schweiz) Ag. The common name of the device is surgical microscope. It has been assigned the product code FSO by the FDA and is classified as a Class I medical device. Intended for improving the visibility of objects through magnification and illumination. |
| Product code | FSO |
| Recalling firm | Leica Microsystems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 24, 2017 |
| FEI number | 3000210133 |
At a glance
- None 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