FDA Device recall Z-2486-2015
Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by: Physician Engineered Products, Inc., Model SBL60
- FDA Device
- Class II
- terminated
- Published 2015-09-09
On 2015-09-09 the FDA classified a Class II recall of Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by: Physician Engineered Products, Inc., Model SBL60 by Physician Engineered Products, citing upper limit for ambient temperature for use of the device was printed incorrectly in the instructions.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2486-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-08-31 |
| Published | 2015-09-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Physician Engineered Products |
| Distribution | CA, CO, FL, KY, MA, MD, NM, PA, TN, TX, VA |
Product
Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by: Physician Engineered Products, Inc., Model SBL60
Reason
Upper limit for ambient temperature for use of the device was printed incorrectly in the instructions
Identifiers
| code_info | Serial Numbers: 1002565 1002579 1002632 1002644 1002655 1002688 1002689 1002736 1002746 1002753-1002762 (10 u…Serial Numbers: 1002565 1002579 1002632 1002644 1002655 1002688 1002689 1002736 1002746 1002753-1002762 (10 units) 1002768-1002788 (21 units) 1002791-1002805 (15 units) 1002807-1002813 (7 units) 1002816-1002823 (8 units) 1002825-1002833 (9 units) 1002835-1002836 (2 units) 1002850-1002865 (16 units) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2486-2015%22
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