Device recall
Z-2250-2017: SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE. Intended for use in the…
FDA device recall · Class II · Circadiance LLC
Key facts
| Recall number (Z-number) | Z-2250-2017 |
|---|---|
| Recall event | 77176 |
| Product | SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE. Intended for use in the continuous monitoring of respiration, heart rate, and SP02 of infant, pediatric and adult patients. |
| Product code | NPE |
| Recalling firm | Circadiance LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 5, 2018 |
| 510(k) numbers | K061256 |
| FEI number | 3006182632 |
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