Events

Alerta De Seguridad para Ultrasound System

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por Esaote S.P.A. || Siemens Ltd. Seoul || Siemens Medical Solutions Usa, Inc..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    I1509-438
  • Número del evento
    2008DM-0001867
  • Fecha
    2015-09-19
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=171
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.

Device

Ultrasound System
  • Modelo / Serial
    ACUSON SC2000
  • Descripción del producto
    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