Events

Recall of Device Recall MyLab

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Biosound Esaote, 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
    32019
  • Event Risk Class
    Class 2
  • Event Number
    Z-1401-05
  • Event Initiated Date
    2005-05-06
  • Event Date Posted
    2005-08-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-10-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38938
  • 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
    System, Imaging, Pulsed Doppler, Ultrasonic - Product Code IYN
  • Reason
    Data may be corrupted upon re-opening archived files.
  • Action
    U.S. distributors were notified via recall letter dated 5/2/05 and U.S. customers were notified via letter dated 5/6/05. Canadian customer were notified via letter dated 5/13/05 and Puerto Rico distributor and customers were ntofied on 5/9/05. The firm is installing new software in the field.

Device

Device Recall MyLab
  • Model / Serial
    All units using software version 3.02: Serial numbers 53, 58, 60, 67, 70, 72, 73, 75 and 79.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Canada and Venezuela.
  • Product Description
    MyLab30CV Ultrasound Imaging System; model 9807300000.
  • Manufacturer
    Biosound Esaote, Inc.

Manufacturer

Biosound Esaote, Inc.
  • Manufacturer Address
    Biosound Esaote, Inc., 8000 Castleway Dr, Indianapolis IN 46250-1943
  • Source
    USFDA