Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2486-2015 — Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by: Physician Engineered Products, Inc., Model SBL60

U.S. FDA — Device Enforcement · United States · 2013-08-31 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2486-2015
Date of alert
2013-08-31
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Physician Engineered Products, Inc.
Product category
device
Product type
Devices
Reported risk: Upper limit for ambient temperature for use of the device was printed incorrectly in the instructions
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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