Events

Alerta De Seguridad para magnetic resonance equipment

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 GE Medical Systems, Llc. || GE Hangwei Medical Systems Co. Ltd || GE Medical Systems Information Technologies Gmbh || GE Medical Systems, Llc (Dba GE Healthcare), || Xinaomdt Technology Co, Ltd || GE Medical Systems Scs || General Medical Merate Spa || GE Healthcare || GE Healthcare Do Brasil Comércio E Servicos Para || Equipamentos Medico-Hospitalares Ltda. || GE Medical Systems Technologies Co Ltd.

¿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
    I1411-486
  • Número del evento
    2007DM-0001028
  • Fecha
    2014-11-24
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=191
  • 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 states that there is the possibility of an error in the orientation of the images causing their investment, when they are acquired using the option psd bundling with the focus excitation mode, leading to the presentation of possible adverse events on the patients.

Device

magnetic resonance equipment

Manufacturer

GE Medical Systems, Llc. || GE Hangwei Medical Systems Co. Ltd || GE Medical Systems Information ...