Physician Engineered Products, Inc.: Medical Device Recall in 2015 - (Recall #: Z-2486-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by: Physician Engineered Products, Inc., Model SBL60

Product Classification:

Class II

Date Initiated: August 31, 2013

Date Posted: September 9, 2015

Recall Number: Z-2486-2015

Event ID: 71803

Reason for Recall:

Upper limit for ambient temperature for use of the device was printed incorrectly in the instructions

Status: Terminated

Product Quantity: 97 units

Code Information:

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)

Distribution Pattern:

Worldwide Distribution - US Distribution to the states of : CA, CO, FL, KY, MA, MD, NM, PA, TN, TX and VA., and to the countries of : Egypt, Honduras, Saudi Arabia and Singapore.

Voluntary or Mandated:

Voluntary: Firm initiated