Device recall
Z-1412-2015: Natus neoBLUE blanket LED Phototherapy system which includes the following…
FDA device recall · Class II · Natus Medical Incorporated
Key facts
| Recall number (Z-number) | Z-1412-2015 |
|---|---|
| Recall event | 70810 |
| Product | Natus neoBLUE blanket LED Phototherapy system which includes the following items: 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy… |
| Product code | LBI |
| Recalling firm | Natus Medical Incorporated |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 20, 2016 |
| 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