FDA-Device2015-09-09Class II
Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by: Physician Engineered Products, Inc., Model SBL60
Physician Engineered Products, Inc.
Hazard
Upper limit for ambient temperature for use of the device was printed incorrectly in the instructions
Sold states
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.
Affected count
97 units
Manufactured in
103 Smith St, N/A, Fryeburg, ME, United States
Products
Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by: Physician Engineered Products, Inc., Model SBL60
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2486-2015Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief