Device recall
Z-1924-2017: Second generation neoBLUE LED Phototherapy Light (neoBLUE 2) sold between 2003…
FDA device recall · Class II · Natus Medical Incorporated
Key facts
| Recall number (Z-number) | Z-1924-2017 |
|---|---|
| Recall event | 74474 |
| Product | Second generation neoBLUE LED Phototherapy Light (neoBLUE 2) sold between 2003 and 2008. Catalog Part Number 010066. Top Assembly Part Numbers: 040906, 040904, 040756, 040758, 040658, 040680. Product Usage: Device is used to provide treatment for neonatal hyperbilirubinemia. |
| Product code | LBI |
| Recalling firm | Natus Medical Incorporated |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 13, 2019 |
| 510(k) numbers | K022196 |
| 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