Events

Safety Alert for Ultrasound System for Diagnosis

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

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
    I1702-41
  • Event Number
    2008DM-0001867
  • Date
    2017-02-14
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=103
  • 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 indicates that with the high definition transducers 6c1, as with the 18l6 hd transducer, errors can be presented when using the instructions that appear on the screen, this problem occurs with greater incidence when using civco biopsy connectors, likewise describe possible alignment errors in the measurement tool when repositioning the iq virtual interest region from its default location, leading to the occurrence of possible serious adverse events on the patient.

Device

Ultrasound System for Diagnosis
  • Model / Serial
  • Product Description
    Ultrasound system for applications of: abdomen, intraoperative, obstetrics and gynecology, pelvis, breast, orthopedics, urology, small parts, transcranial, skeletal muscle, vascular, peripheral vascular, cardiology, intracardiac and transplasia for neonatal, pediatric and adult patients.
  • Manufacturer
    Siemens Medical Solutions Usa, Inc. || Esaote S.P.A || Siemens Ltd. Seoul

Manufacturer

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