Events

Safety Alert for Ultrasound

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Esaote Europe || Esaote S.P.A..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    I1608-356
  • Event Number
    2010DM-0005616
  • Date
    2016-08-22
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=125
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Colombia.
  • Extra notes in the data
  • Reason
    The manufacturer that has detected the possibility of a mechanical failure due to the detachment of the welding in the lower structure that houses the wheels, causing the possible fall to the ground or its overturning, leading to the occurrence of possible adverse events on the patients or users.

Device

Ultrasound
  • Model / Serial
    MYLAB TWICE, specific serials.
  • Product Description
    Ultrasound equipment for applications: cardiac, adult, pediatric, neonatal, general images, gynecology, obstetrics, transcephalic, skeletal muscle, small parts anesthesia and urology. With XMA technology, XHF, XVIEW, XFT, XBF, with color 3D Doppler, 4D.
  • Manufacturer
    Esaote Europe || Esaote S.P.A.

Manufacturer

Esaote Europe || Esaote S.P.A.