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Terminated

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

FDA Recall Z-2486-2015 · Posted 2015-08-31

Recalling FirmPhysician Engineered Products, Inc.
Recall StatusTerminated
Product CodeLBI
Date Initiated2013-08-31
Date Terminated2015-09-02
Product Quantity97 units

Reason for Recall

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

Firm Action

Physician Engineered Products, Inc. sent an Bright Embrace Recall notification dated September 10, 2013, to notify customers of the recall of the Bright Embrace . PEP is issuing a Return Authorization to you. Upon receipt PEP will reimburse to you: 1) The cost of the device(s) 2) Shipping costs-both from and to PEP For further questions please call (207) 935-1256.

Root Cause

Device Design

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K110550BRIGHT EMBRACE MODEL SBL60Physician Engineered Products, Inc. · 2012-02-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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