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

FDA device recall Z-2165-2010 · posted 2010-08-03 · Terminated

Recall details

Recalling firm

Natus Medical Inc

Reason for recall

There is insufficient evidence to support any claims for safety and efficacy on the SonaMed Clarity devices.

Action taken

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.

Root cause

PMA

Status

Terminated

Product code

GWJ

Quantity affected

284 units

Distribution

Nationwide Distribution

Date initiated

2010-06-04

Date posted

2010-08-03

Date terminated

2011-06-22

Location

Mundelein, IL

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