Events

Recall of Device Recall SoundBite Microphone Tube

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sonitus Medical Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    61114
  • Event Risk Class
    Class 3
  • Event Number
    Z-1180-2012
  • Event Initiated Date
    2012-02-02
  • Event Date Posted
    2012-03-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107327
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Hearing aid, bone conduction - Product Code LXB
  • 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.

Device

Device Recall SoundBite Microphone Tube
  • Model / Serial
    Model number P02013 - Right, lot M1098, M1106 and P020014 - Left, lot M109, M1102 and M1107.
  • Product Classification
    Ear, Nose, and Throat Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Class III Recall - Nationwide Distribution, including the states of CA, AZ, PA, MI, UT, NC, NY, WI, TX, FL and DC.
  • Product Description
    SoundBite Hearing System; Microphone Tube Size 1. 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.
  • Manufacturer
    Sonitus Medical Inc.

Manufacturer

Sonitus Medical Inc.
  • Manufacturer Address
    Sonitus Medical Inc., 1825 S Grant St Ste 350, San Mateo CA 94402-7033
  • Manufacturer Parent Company (2017)
    Sonitus Medical Inc.
  • Source
    USFDA