SoundBite Hearing System; Microphone Tube Size 2. For use in patients with moderately severe, severe or profound sensori
FDA device recall Z-1181-2012 · posted 2012-03-07 · Terminated
Recall details
- Recalling firm
- Sonitus Medical Inc.
- Reason for recall
- Sonitas received reports of stress cracking on the SoundBite Microphone Tube.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LXB
- Quantity affected
- 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.
- Date initiated
- 2012-02-02
- Date posted
- 2012-03-07
- Date terminated
- 2012-03-23
- Location
- San Mateo, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SOUNDBITE HEARING SYSTEM BY SONITUS MEDICAL (K110831) | Sonitus Medical, Inc. | 2011-06-21 |