Device recall
Z-1387-2011: Masimo Hemoglobin Pronto-7 with Rainbow 40 Technology for easy-to-use spot-check…
FDA device recall · Class II · Masimo Corporation
Key facts
| Recall number (Z-number) | Z-1387-2011 |
|---|---|
| Recall event | 57700 |
| Product | Masimo Hemoglobin Pronto-7 with Rainbow 40 Technology for easy-to-use spot-check testing of hemoglobin (SpHb), SpO2, pulse rate, and perfusion index Pronto-7 rainbow 4D Reusable Sensors are an accessory to the Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter. The Masimo Rainbow SET Pronto-7 Pulse… |
| Product code | DQA |
| Recalling firm | Masimo Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 26, 2013 |
| 510(k) numbers | K100403 |
| 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