Z-2165-2010

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

Name: Z-2165-2010 SonaMed Clarity System II; evoked response auditory stimulator; SonaMed Corp., Waltham, MA 02154
Creator: Natus Medical Inc
Published: 2010-06-04
License: https://open.fda.gov/license/

Bio-Logic Systems Corp. / initiated 2010-06-04 / Terminated

FDA source

Natus Medical Inc began a recall of SonaMed Clarity System II; evoked response auditory stimulator; SonaMed Corp., Waltham, MA 02154 on 2010-06-04. The reason FDA records is "There is insufficient evidence to support any claims for safety and efficacy on the SonaMed Clarity devices". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2165-2010
Status: Terminated
Initiated: 2010-06-04
Posted: 2010-08-03
Terminated: 2011-06-22
Recalling firm: Bio-Logic Systems Corp.
Product: SonaMed Clarity System II; evoked response auditory stimulator; SonaMed Corp., Waltham, MA 02154
Product code: GWJ Stimulator, Auditory, Evoked Response
Reason for recall: There is insufficient evidence to support any claims for safety and efficacy on the SonaMed Clarity devices.
FDA root cause: 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
Product codes and lots: all models, all serial numbers

Product code GWJ

K952080Class IIClarity System IISonamed Corp. / cleared 1995-09-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)