SoundBite Hearing System; Microphone Tube Size 4. 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.
FDA Recall Z-1183-2012 · Posted 2012-03-07
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Recalling FirmSonitus Medical Inc.
Recall StatusTerminated
Product CodeLXB
Date Initiated2012-02-02
Date Terminated2012-03-23
Product Quantity676 microphones, all sizes.
Reason for Recall
Sonitas received reports of stress cracking on the SoundBite Microphone Tube.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Class III Recall - Nationwide Distribution, including the states of CA, AZ, PA, MI, UT, NC, NY, WI, TX, FL and DC.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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