Device recall
Z-0213-2015: Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-line…
FDA device recall · Class II · Masimo Corporation
Key facts
| Recall number (Z-number) | Z-0213-2015 |
|---|---|
| Recall event | 69504 |
| Product | Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-line cable that provides continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate when installed in a compatible OEM host system. Shipping/Package: All Pulse Oximetry… |
| Product code | DQA |
| Recalling firm | Masimo Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 28, 2016 |
| 510(k) numbers | K121914 |
| FEI number | 3001452206 |
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