Device recall
Z-1551-2014: Nellcor SpO2 Upgrade kit, consists of a Nellcor SpO2 circuit board, an OEM part…
FDA device recall · Class II · GE Healthcare
Key facts
| Recall number (Z-number) | Z-1551-2014 |
|---|---|
| Recall event | 68067 |
| Product | Nellcor SpO2 Upgrade kit, consists of a Nellcor SpO2 circuit board, an OEM part manufactured by a third party supplier; and an integral component of the Nellcor SpO2 device. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated… |
| Product code | FMT |
| Recalling firm | GE Healthcare |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 11, 2016 |
| FEI number | 1121732 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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