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U.S. Department of Health and Human Services

Class 3 Device Recall SoundBite Microphone Tube

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  Class 3 Device Recall SoundBite Microphone Tube see related information
Date Initiated by Firm February 02, 2012
Date Posted March 07, 2012
Recall Status1 Terminated 3 on March 23, 2012
Recall Number Z-1182-2012
Recall Event ID 61114
510(K)Number K110831  
Product Classification Hearing aid, bone conduction - Product Code LXB
Product 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.
Code Information Model number P02017 - Right,lot M1100 and P020018 - Left, lot M1104, M1097.
Recalling Firm/
Manufacturer		 Sonitus Medical Inc.
1825 S Grant St Ste 350
San Mateo CA 94402-7033
For Additional Information Contact Viorica Filimon
650-251-4185
Manufacturer Reason
for Recall		 Sonitas received reports of stress cracking on the SoundBite Microphone Tube.
FDA Determined
Cause 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LXB and Original Applicant = SONITUS MEDICAL INC
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