Alerta De Seguridad para BrightView

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 Philips Medical Systems (Cleveland) Inc. || Philips Nuclear Medicine 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
    I1504-146
  • Número del evento
    2008DM-0001422
  • Fecha
    2015-04-16
  • País del evento
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
  • 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 claims that the detectors in the referenced medical devices can come into contact with the floor while being repositioned between examinations when the system is in the preprogrammed mode of movement causing damage to the equipment, leading to potentially adverse events occurring to patients or users.

Device

  • Modelo / Serial
    BRIGHTVIEW, BRIGHTVIEW X and BRIGHTVIEW XCT
  • Descripción del producto
    Clinical diagnosis system by nuclear medicine designed to produce diagnostic images from the detection of radiation that is previously supplied to the patient through a radioactive drug or tracer radioactive with a drug known metabolic pathway.
  • Manufacturer

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    NIDFSINVIMA