Recall Z-2165-2010 ยท GWJ Stimulator, Auditory, Evoked Response
Natus Medical Inc
SonaMed Clarity System II; evoked response auditory stimulator; SonaMed Corp., Waltham, MA 02154
| Date | Aug 3, 2010 (initiated Jun 4, 2010) |
| Status | Terminated |
| 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 |
| Quantity | 284 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K952080 | CLARITY SYSTEM II Sonamed Corp., Sep 19, 1995 |