Device recall
Z-2536-2020: The CapsoCam Plus (SV-3); Device Common Name: System, Imaging, Gastrointestinal…
FDA device recall · Class II · Capso Vision, Inc.
Key facts
| Recall number (Z-number) | Z-2536-2020 |
|---|---|
| Recall event | 85540 |
| Product | The CapsoCam Plus (SV-3); Device Common Name: System, Imaging, Gastrointestinal, Wireless, Capsule; Catalog Number 2795 - Product Usage: intended for visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small bowel. |
| Product code | NEZ |
| Recalling firm | Capso Vision, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 28, 2021 |
| 510(k) numbers | K192662 |
| FEI number | 3008062894 |
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