BEUDAMED
    FDA Recall Terminated

    SonaMed Clarity System II; evoked response auditory stimulator; SonaMed Corp., Waltham, MA 02154

    Recall: Z-2165-2010 · Initiated June 4, 2010

    Recall

    Recall Number
    Z-2165-2010
    Event Number
    56055
    Firm
    Natus Medical Inc
    FEI Number
    1419887
    Product Code
    GWJ
    Status
    Terminated
    Root Cause
    PMA
    Initiated
    June 4, 2010
    Posted
    August 3, 2010
    Terminated
    June 22, 2011
    Address
    1 Bio Logic Plaza, Mundelein, IL, 60060-3708

    Description

    SonaMed Clarity System II; evoked response auditory stimulator; SonaMed Corp., Waltham, MA 02154

    Reason

    There is insufficient evidence to support any claims for safety and efficacy on the SonaMed Clarity devices.

    Action

    Natus sent Urgent Medical Device Recall letters dated 6/4/10 to all known SonaMed Clarity device accounts, to the attention of the Director of Maternal Child Health and the Risk Manager. The letters referenced the letters previously sent to them by Natus in October 2008 and April 2010 informing them of Natus' concerns about whether the Clarity device could be lawfully used to comply with FDA-related requirements and other pertinent professional guidelines/standards for newborn infant hearing screening, and that they concluded that the Clarity devices should no longer be used. Natus recognized the need for the accounts to continue screening without interruption, and are providing on loan at no-charge handheld screener(s) to facilities that do not have alternate screening devices. The accounts were requested to contact Natus Technical Service group at 800-272-8075 to discuss this loaner device option. Natus requested that the accounts stop using the SonaMed Clarity devices; disable the screening function of their Clarity system(s) by returning to Natus, in the enclosed pre-addressed return envelope, either of the two probes (TPI-830- 8-pin ear probe, or the TPI-815- 7-pin ear probe) they may possess and have used in screening, making sure to return all 7- or 8-pin probes for all of your Clarity systems; and complete the attached "Device Recall Reply Form" and return it in the enclosed self-addressed stamped envelope. If you have any questions concerning any aspect of this recall notice, please call Natus Technical Support at 1-800-272-8075.

    Distribution

    Nationwide Distribution

    Quantity

    284 units