Events

Alerta De Seguridad para Body Composition Analyzer INBODY

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 Biospace Co. Ltd. || Inbody Co., Ltd || BTS S.P.A..

¿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
    R1711-528
  • Número del evento
    2013DM-0009968 ; 2013DM-0010753
  • Fecha
    2017-11-16
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=65
  • 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
    Invima informs that through ivc's visit it was possible to prove that the referenced product was marketed without complying with the full requirements demanded by the technical and legal provisions that regulate it, for which the product recall was requested in a preventive manner, as it is considered a fraudulent product.

Device

Body Composition Analyzer INBODY
  • Modelo / Serial
  • Descripción del producto
    Body composition analyzer INBODY performs an analysis by bioelectrical impedance (BIA) in a segmental, multifrequency and octopolar way, emits results regarding: 1-diagnosis of obesity 2-edema 3- nutritional evaluation 4-evaluation of weight 5-body balance 6- body strength 7-weight control 8- BMR 9- health score Human body movement analysis for orthopedics and rehabilitation, prostheses and orthoses, sports medicine, respiratory therapy, ergonomics and occupational health.
  • Manufacturer
    Biospace Co. Ltd. || Inbody Co., Ltd || BTS S.P.A.

Manufacturer

Biospace Co. Ltd. || Inbody Co., Ltd || BTS S.P.A.
  • Source
    NIDFSINVIMA