Device recall
Z-1301-2010: Spanish 100-120V 515B Pulse Oximeter - Dixtal owned product. Intended use is to…
FDA device recall · Class II · Philips Healthcare Inc.
Key facts
| Recall number (Z-number) | Z-1301-2010 |
|---|---|
| Recall event | 53869 |
| Product | Spanish 100-120V 515B Pulse Oximeter - Dixtal owned product. Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate. |
| Product code | DQA |
| Recalling firm | Philips Healthcare Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 8, 2016 |
| 510(k) numbers | K893643 |
| FEI number | 1218950 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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