Device recall
Z-0046-2020: Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE.
FDA device recall · Class II · Leica Biosystems Imaging, Inc.
Key facts
| Recall number (Z-number) | Z-0046-2020 |
|---|---|
| Recall event | 83383 |
| Product | Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE. |
| Product code | NOT |
| Recalling firm | Leica Biosystems Imaging, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 28, 2021 |
| 510(k) numbers | K141109 |
| FEI number | 3006791373 |
At a glance
- 1–9 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