Events

Alerta De Seguridad para Ultrasound System for Diagnosis

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

¿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
    I1702-41
  • Número del evento
    2008DM-0001867
  • Fecha
    2017-02-14
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=103
  • 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 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
  • Modelo / Serial
  • Descripción del producto
    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