Home / Recalls / Physician Engineered Products, Inc. / Z-2486-2015

Z-2486-2015 Class II Terminated

Recalled by Physician Engineered Products, Inc. — Fryeburg, ME

Recall Details

Product Type: Devices
Report Date: September 9, 2015
Initiation Date: August 31, 2013
Termination Date: September 2, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 97 units

Product Description

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

Reason for Recall

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

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.

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)