Device recall
Z-0338-2016: rainbow Reusable Sensors. RAINBOW DCI-DC3, SpO2/SpCO/SpMet, Part No. 2201…
FDA device recall · Class II · Masimo Corporation
Key facts
| Recall number (Z-number) | Z-0338-2016 |
|---|---|
| Recall event | 72626 |
| Product | rainbow Reusable Sensors. RAINBOW DCI-DC3, SpO2/SpCO/SpMet, Part No. 2201; RAINBOW DCI-dc8, SpO2/SpCO/SpMet, Part No. 2407; RAINBOW DCI, SpO2/SpCO/SpMet, Part No. 2696; RAINBOW DCIP, PED, SpO2/SpCO/SpMet, Part No. 2697. rainbow reusable sensors are indicated for spot check or continuous non-invasive… |
| Product code | DQA |
| Recalling firm | Masimo Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 18, 2016 |
| 510(k) numbers | K080238 |
| 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