Device recall
Z-1411-2009: SmartMonitor 2 Infant Apnea Monitor. The monitor is intended for use in the…
FDA device recall · Class I · Respironics, Inc.
Key facts
| Recall number (Z-number) | Z-1411-2009 |
|---|---|
| Recall event | 51886 |
| Product | SmartMonitor 2 Infant Apnea Monitor. The monitor is intended for use in the continuous monitoring of respiration and heart rate of infant patients in a home or hospital environment. The monitor detects and alarms for periods of central apnea and high or low heart rates. |
| Product code | FLS |
| Recalling firm | Respironics, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Oct 19, 2011 |
| 510(k) numbers | K011597 |
| FEI number | 2518422 |
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