Events

Recall of Device Recall Sonotrax

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Danatech Medical Systems 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
    27882
  • Event Risk Class
    Class 2
  • Event Number
    Z-0232-04
  • Event Initiated Date
    2003-12-05
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-10-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30682
  • 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
    Monitor, Fetal Doppler Ultrasound - Product Code MAA
  • Reason
    This prescription device, without an approved 510k , was distributed to unauthorized consumers, mostly pregnant women, on the internet.
  • Action
    The firm mailed via overnight priority mail, a recall notification letter with response form to consignees on 12/5/2003 requesting return of the product and refund.

Device

Device Recall Sonotrax
  • Model / Serial
    Product is uncoded.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed to 89 consumers nationwide.
  • Product Description
    Product is a handheld fetal Doppler used to screen for fetal heart rate and averaged fetal heart rate and is labeled as: Sonotrax Handheld Fetal Doppler Series and includes the Basic and Lite models.
  • Manufacturer
    Danatech Medical Systems Inc

Manufacturer

Danatech Medical Systems Inc
  • Manufacturer Address
    Danatech Medical Systems Inc, 7275 Nw 68th St Ste 1, Miami FL 33166-3094
  • Source
    USFDA