Events

Alerta De Seguridad para Model 7700 Mobile C-Arm Fluoroscopic X-Ray Digital Imaging Systems: (1) Compact, (2) 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
    229
  • 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 aforementioned x-ray diagnostic systems require replacement of the printed circuit board to enable x-ray initiation. it is possible for the operator to wrap the foot pedal cord around the pedal and press the whip into the foot pedal holder after finishing using the system, the next activation of the system could activate the foot pedal inside its pedestal , by triggering the x-ray, exposing the operator and the patient. the aforementioned x-ray diagnostic systems were defective in accordance with 21 cfr 1003.10 guidelines and did not meet the performance standard of 21 cfr 1020.32 (c). the systems mentioned also did not meet the performance standard of 21 cfr 1020.32 (c) of fluoroscopic performance. "fluoroscopic mode x-ray production should be controlled by equipment requiring continuous operator pressure for the duration of any exposure . " the manufacturer initiated a correction by registered letter sent on july 19, 2000. the fda approved the company's corrective action plan on october 26, 2000.
  • Acción
    Make sure you have received the correspondence sent on July 19, 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) 328-9330 in the United States.

Device

Model 7700 Mobile C-Arm Fluoroscopic X-Ray Digital Imaging Systems: (1) Compact, (2) Series

Manufacturer

GE OEC Medical Systems
  • Source
    ANVSANVISA