Safety Alert for Ultrasound System

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Esaote S.P.A. || Siemens Ltd. Seoul || Siemens Medical Solutions Usa, Inc..

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
  • Event Number
  • Date
  • Event Country
  • Event Source
  • Event Source URL
  • 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 has determined that even though the original study has been removed from the hard disk and that the difference in the case (case) income was not fulfilled, the system considers that several patients registered, the uppercase and lowercase these differences do not account for what is not corrected during the recording therefore it does not capture images or videos, which could lead to the potential loss of diagnostic information, generating possible adverse events on the patient.


  • Model / Serial
    ACUSON SC2000
  • Product Description
    Ultrasound system for applications of: abdomen, intraoperative, obstetrics and gynecology, pelvis, breast, orthopedics, urology, small parts, transcranial, musculoskeletal, vascular, peripheral vascular, cardiology, intracardiac and transesophagy for neonatal, pediatric and adult patients.
  • Manufacturer