Device recall
Z-1867-2018: PHILIPS Xper Flex Cardio Physiomonitoring System, Model Numbers: 453564241901…
FDA device recall · Class II · Invivo Corporation
Key facts
| Recall number (Z-number) | Z-1867-2018 |
|---|---|
| Recall event | 79611 |
| Product | PHILIPS Xper Flex Cardio Physiomonitoring System, Model Numbers: 453564241901, 453564483321, 453564621791, and 989803199561 (international only) The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular, disease when non-invasive indicators… |
| Product code | MWI |
| Recalling firm | Invivo Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 30, 2021 |
| FEI number | 1051786 |
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