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 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
    I1508-356
  • Event Number
    2008DM-0001867
  • Date
    2015-08-04
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=174
  • 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 it has made a recent finding in relation to the needle guides, where two transducers (6c1 hd and hd 18l6) show misalignment in their use with reference to the guidelines that appear on the screen, leading to the occurrence of potential errors in the measurement and subsequent diagnosis.

Device

Ultrasound System
  • Model / Serial
    ACUSON S1000, ACUSON S2000 and ACUSON S3000
  • 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 Ltd. Seoul || Siemens Medical Solutions Usa, Inc.

Manufacturer

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