BEUDAMED
    FDA Enforcement Class II Terminated

    Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototherapy system. Neonatal phototherapy.

    Recall: Z-0847-2015 · Reported December 31, 2014

    Enforcement

    Recall Number
    Z-0847-2015
    Event ID
    69820
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Natus Medical Incorporated
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 31, 2014
    Initiation Date
    November 19, 2014
    Classification Date
    December 22, 2014
    Termination Date
    July 20, 2015
    Address
    5900 1st Ave S, Seattle, WA, 98108-3248, United States

    Description

    Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototherapy system. Neonatal phototherapy.

    Reason

    Replacement LED Board kit of Natus neoBLUE2 Phototherapy system distributed after February 16, 2012 is subject of a Field Safety Notification because the system will exhibit a higher light intensity output than the original device. While some customers may prefer using these lights at the higher intensity levels, some are concerned that patients may receive more intensity than desired.

    Code Info

    All distributed Natus neoBLUE 2 systems with LED PCB replacements received after February 16, 2012. For use only with neoBLUE devices manufactured between 2002 and 2007 (neoBLUE2)

    Distribution

    worldwide

    Quantity

    1907 total (1413 in US and 494 international)