Device recall
Z-1187-2013: Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories are…
FDA device recall · Class II · Masimo Corporation
Key facts
| Recall number (Z-number) | Z-1187-2013 |
|---|---|
| Recall event | 64812 |
| Product | Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories are indicated for the continuous, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). |
| Product code | DQA |
| Recalling firm | Masimo Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 10, 2015 |
| FEI number | 3001452206 |
At a glance
- None 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