Device recall
Z-0263-2018: Xper Flex Cardio Physiomonitoring system. Used to facilitate invasive…
FDA device recall · Class II · Invivo Corporation
Key facts
| Recall number (Z-number) | Z-0263-2018 |
|---|---|
| Recall event | 78585 |
| Product | Xper Flex Cardio Physiomonitoring system. Used to facilitate invasive investigations of heart and vascular disease when non-invasive indicators warrant such. |
| Product code | MWI |
| Recalling firm | Invivo Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 20, 2024 |
| 510(k) numbers | K101571 |
| FEI number | 1051786 |
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