Device recall
Z-1559-2009: Dixtal Novametrix Neonatal/Pediatric SpO2 Sensor, Foam Wrap Style Catalog #…
FDA device recall · Class II · Dixtal Medical, Inc.
Key facts
| Recall number (Z-number) | Z-1559-2009 |
|---|---|
| Recall event | 52041 |
| Product | Dixtal Novametrix Neonatal/Pediatric SpO2 Sensor, Foam Wrap Style Catalog #: 6480-25. The SpO2 Foam Wrap Style (Single Patient Use) Sensors are intended to be used to provide for the measurement of the patient's arterial oxygen saturation and pulse rate when connected to Dixtal Medical Pulse… |
| Product code | DQA |
| Recalling firm | Dixtal Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 23, 2012 |
| 510(k) numbers | K913516 |
| FEI number | 3006891479 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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