BEUDAMED
    FDA Recall Terminated

    The Natus Blue Light Phototherapy is also called the "neoBLUE LED Phototherapy System". The "neoBLUE mini LED Phototherapy System"

    Recall: Z-0420-2010 · Initiated October 1, 2009

    Recall

    Recall Number
    Z-0420-2010
    Event Number
    53681
    Firm
    Natus Medical Incorporated
    FEI Number
    3018859
    Product Code
    LBI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 1, 2009
    Posted
    November 24, 2009
    Terminated
    September 22, 2011
    Address
    5900 1st Ave S, Seattle, WA, 98108-3248

    Description

    The Natus Blue Light Phototherapy is also called the "neoBLUE LED Phototherapy System". The "neoBLUE mini LED Phototherapy System"

    Reason

    The clamp connecting the neoBLUE mini phototherapy light to the accessory pole stand can sustain stress fractures or break when excessive force is used when tightening the clamp. No injuries have been reported.

    Action

    On 10/1/09 Natus notified domestic consignees by Urgent Product Advisory Notice letter that advised them of the issue, instructed them to inspect the clamps, and included pictures of the affected clamp. Consignees are instructed to return the recalled clamps for a new replacement to be shipped by Natus. International distribution partners were notified by letter on 10/1/2009 and instructed to identify and contact their consignees. Replacements will be sent to the distribution partner for their consignees.

    Distribution

    Worldwide distribution: USA, Argentina, Australia, Austria, Belgium, Bermuda, Canada, Chile, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Kenya, Kuwait, Lithuania, Malaysia, Mexico, Morocco, Netherlands, Norway, Philippines, Poland, Portugal, PR, Qatar, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, and UK

    Quantity

    2127