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U.S. Department of Health and Human Services

Class 2 Device Recall SonaMed Clarity System

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  Class 2 Device Recall SonaMed Clarity System see related information
Date Initiated by Firm June 04, 2010
Date Posted August 03, 2010
Recall Status1 Terminated 3 on June 22, 2011
Recall Number Z-2165-2010
Recall Event ID 56055
510(K)Number K952080  
Product Classification Evoked Response Auditory Stimulator - Product Code GWJ
Product SonaMed Clarity System II; evoked response auditory stimulator; SonaMed Corp., Waltham, MA 02154
Code Information all models, all serial numbers
Recalling Firm/
Manufacturer		 Natus Medical Inc
1 Bio Logic Plaza
Mundelein IL 60060-3708
For Additional Information Contact Mr. Don Williams
847-949-5200
Manufacturer Reason
for Recall		 There is insufficient evidence to support any claims for safety and efficacy on the SonaMed Clarity devices.
FDA Determined
Cause 2		 PMA
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.
Quantity in Commerce 284 units
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GWJ and Original Applicant = SONAMED CORP.
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