Events

Recall of Device Recall SonaMed Clarity System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Natus Medical Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    56055
  • Event Risk Class
    Class 2
  • Event Number
    Z-2165-2010
  • Event Initiated Date
    2010-06-04
  • Event Date Posted
    2010-08-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-06-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92553
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Evoked Response Auditory Stimulator - Product Code GWJ
  • 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.

Device

Device Recall SonaMed Clarity System
  • Model / Serial
    all models, all serial numbers
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    SonaMed Clarity System II; evoked response auditory stimulator; SonaMed Corp., Waltham, MA 02154
  • Manufacturer
    Natus Medical Inc

Manufacturer

Natus Medical Inc
  • Manufacturer Address
    Natus Medical Inc, 1 Bio Logic Plaza, Mundelein IL 60060-3708
  • Manufacturer Parent Company (2017)
    Natus Medical Incorporated
  • Source
    USFDA