Events

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
    I1508-418
  • Event Number
    2008DM-0001867
  • Date
    2015-08-27
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=172
  • 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 states that the teams referenced when performing a study in 2d stress echo mode and with a specific manipulation of the keys, could lead to a possible loss of data, where some selected videos will be recorded as part of the study, leading to the presentation of possible adverse events on the patients or difficulties in the diagnosis.

Device

Ultrasound System
  • Model / Serial
    ACUSON SC2000, software version VA16A up to VA30A
  • 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
    Esaote S.P.A. || Siemens Ltd. Seoul || Siemens Medical Solutions Usa, Inc.

Manufacturer

Esaote S.P.A. || Siemens Ltd. Seoul || Siemens Medical Solutions Usa, Inc.
  • Source
    NIDFSINVIMA