Events

Alerta De Seguridad para Model 9800 Series Mobile C-Arm Fluoroscopic X-Ray Digital Imaging Systems. 9800 Series

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por GE OEC Medical Systems.

¿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
    230
  • Fecha
    2000-12-15
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notas adicionales en la data
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    The x-ray systems mentioned require an upgrade to the -07 or 08 version of the system program. affected equipment indicates that the x-ray is being produced when operators take their foot off the pedal, however, the x-ray is not being produced and the indicator light and beep work incorrectly. the described x-ray systems were considered defective according to 21 cfr 1003.10. the manufacturer initiated a correction by registered letter dated april 21, 2000. the fda approved the company's corrective action plan on october 26, 2000.
  • Acción
    Make sure you have received the correspondence sent on April 21, 2000, by GE OEC Medical Systems. Identify and collect any affected product from your inventory. For more information, contact your local representative or directly with GE OEC Medical Systems at (801) 328-9300 in the United States.

Device

Model 9800 Series Mobile C-Arm Fluoroscopic X-Ray Digital Imaging Systems. 9800 Series

Manufacturer

GE OEC Medical Systems
  • Source
    ANVSANVISA