Device recall
Z-0769-2017: Updated Natus neoBLUE blanket LED Phototherapy Systems. It provides phototherapy…
FDA device recall · Class II · Natus Medical Incorporated
Key facts
| Recall number (Z-number) | Z-0769-2017 |
|---|---|
| Recall event | 75228 |
| Product | Updated Natus neoBLUE blanket LED Phototherapy Systems. It provides phototherapy underneath the infant and can be used in a bassinet, open bed, radiant warmer, incubator, or while holding the infant. Affected systems including: 1) Updated light boxes (serial number xxxx004283 or greater) have… |
| Product code | LBI |
| Recalling firm | Natus Medical Incorporated |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 1, 2017 |
| 510(k) numbers | K103589 |
| FEI number | 3018859 |
At a glance
- 1–9 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