Device recall
Z-1926-2019: CLEO Patient Monitor /Tranquility VS Patient Monitor
FDA device recall · Class II · Infinium Medical, Inc
Key facts
| Recall number (Z-number) | Z-1926-2019 |
|---|---|
| Recall event | 82999 |
| Product | CLEO Patient Monitor /Tranquility VS Patient Monitor |
| Product code | MWI |
| Recalling firm | Infinium Medical, Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K142244 |
| FEI number | 3007513035 |
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