Recall Z-1182-2012 ยท LXB Hearing Aid, Bone Conduction
Sonitus Medical Inc.
SoundBite Hearing System; Microphone Tube Size 3. For use in patients with moderately severe, severe or profound sensorineural hearing loss in one ear and normal hearing in the other or patients with conductive hearing loss where the pure tone average bond-conduction hearing threshold is better than or equal to 25 dB HL. Sonitus Medical, San Mateo, CA.
| Date | Mar 7, 2012 (initiated Feb 2, 2012) |
| Status | Terminated |
| Reason | Sonitas received reports of stress cracking on the SoundBite Microphone Tube. |
| Root cause | Nonconforming Material/Component |
| Action | Letters were sent to all direct SoundBite customers on February 9, 2012 via certified mail. Customers were asked to remove the old microphone tubes and replace with the new enclosed microphone tubes. Return mail instructions were provided for the old microphone tubes. Customer questions were directed to 650-251-4185. |
| Quantity | 676 microphones, all sizes. |
| Distribution | Class III Recall - Nationwide Distribution, including the states of CA, AZ, PA, MI, UT, NC, NY, WI, TX, FL and DC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110831 | SOUNDBITE HEARING SYSTEM BY SONITUS MEDICAL Sonitus Medical, Inc., Jun 21, 2011 |