Device recall
Z-2486-2015: Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by…
FDA device recall · Class II · Physician Engineered Products, Inc.
Key facts
| Recall number (Z-number) | Z-2486-2015 |
|---|---|
| Recall event | 71803 |
| Product | Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by: Physician Engineered Products, Inc., Model SBL60 |
| Product code | LBI |
| Recalling firm | Physician Engineered Products, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 2, 2015 |
| 510(k) numbers | K110550 |
| FEI number | 2183604 |
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