BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-1183-2012 · Initiated February 2, 2012

    Recall

    Recall Number
    Z-1183-2012
    Event Number
    61114
    Firm
    Sonitus Medical Inc.
    FEI Number
    3009200826
    Product Code
    LXB
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 2, 2012
    Posted
    March 7, 2012
    Terminated
    March 23, 2012
    Address
    1825 S Grant St, Ste 350, San Mateo, CA, 94402-7033

    Description

    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.

    Reason

    Sonitas received reports of stress cracking on the SoundBite Microphone Tube.

    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.

    Distribution

    Class III Recall - Nationwide Distribution, including the states of CA, AZ, PA, MI, UT, NC, NY, WI, TX, FL and DC.

    Quantity

    676 microphones, all sizes.