BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-2486-2015 · Reported September 9, 2015

    Enforcement

    Recall Number
    Z-2486-2015
    Event ID
    71803
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Physician Engineered Products, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 9, 2015
    Initiation Date
    August 31, 2013
    Classification Date
    August 31, 2015
    Termination Date
    September 2, 2015
    Address
    103 Smith St, N/A, Fryeburg, ME, 04037-1182, United States

    Description

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

    Reason

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

    Code Info

    Serial Numbers: 1002565 1002579 1002632 1002644 1002655 1002688 1002689 1002736 1002746 1002753-1002762 (10 units) 1002768-1002788 (21 units) 1002791-1002805 (15 units) 1002807-1002813 (7 units) 1002816-1002823 (8 units) 1002825-1002833 (9 units) 1002835-1002836 (2 units) 1002850-1002865 (16 units)

    Distribution

    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.

    Quantity

    97 units