FDA Medical Device Recalls (openFDA)
Natus Medical Inc: SonaMed Clarity System II; evoked response auditory stimulator; SonaMed Corp., Waltham, MA 02154
- Recall number
- Z-2165-2010
- Recalling firm
- Natus Medical Inc
- Product
- SonaMed Clarity System II; evoked response auditory stimulator; SonaMed Corp., Waltham, MA 02154
- Status
- Terminated
- Initiated
- 2010-06-04
- Posted
- 2010-08-03
- Terminated
- 2011-06-22
- Reason
- There is insufficient evidence to support any claims for safety and efficacy on the SonaMed Clarity devices.
- 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
- 284 units
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- all models, all serial numbers
- 510(k) numbers
- ["K952080"]
- PMA numbers
- not on file
- Product code
- GWJ
- Firm FEI
- 1419887
- Firm city
- Mundelein
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28