Home / Recalls / Medical Devices
Physician Engineered Products, Inc. recalls Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by: Physician Engineered Products, Inc., Mo
Recalled September 9, 2015 · FDA recall Z-2486-2015 · Physician Engineered Products
Hazard
Upper limit for ambient temperature for use of the device was printed incorrectly in the instructions · FDA Class II
Units
97 units
Sold at
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.
Description
Upper limit for ambient temperature for use of the device was printed incorrectly in the instructions
Product
Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by: Physician Engineered Products, Inc., Model SBL60
Manufacturer(s)
Physician Engineered Products, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →