Physician Engineered Products, Inc. recalls Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by: Physician Engineered Products, Inc., Model…
- Recall date
- August 31, 2013
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2486-2015
- FDA classification
- Class II
- Brand / firm
- Physician Engineered Products, Inc.
- Sold / distributed
- 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.
Why it was recalled
Upper limit for ambient temperature for use of the device was printed incorrectly in the instructions
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by: Physician Engineered Products, Inc., Model SBL60
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