Device recall
Z-2077-2019: PulsioFlex Monitoring System, Part Number: 6882747, Model Number: PC400 3 R0…
FDA device recall · Class II · GETINGE US SALES LLC
Key facts
| Recall number (Z-number) | Z-2077-2019 |
|---|---|
| Recall event | 83233 |
| Product | PulsioFlex Monitoring System, Part Number: 6882747, Model Number: PC400 3 R0. Usage: The PulsioFlex Monitoring System is indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. If a patient s biometric data are entered, the PulsioFlex Monitor presents the… |
| Product code | DXG |
| Recalling firm | GETINGE US SALES LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 24, 2020 |
| 510(k) numbers | K172259 |
| FEI number | 3012092534 |
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