Retiro De Equipo (Recall) de BRIVO XR285AMX X-RAY SYSTEM

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE).

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
  • ID del evento
  • Clase de Riesgo del Evento
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    The reason for the recall is because when the collimator is rotated beyond 10 degrees from the 0 degree setting relative to the x-ray tube the total misalignment of the edges of the visually defined field with the respective edges of the x-ray field along either the length or the width exceeds 2 percent of the distance from the source to the center of the visually defined field. this is not compliant with iec 60601-1. when the collimator is rotated relative to the x-ray tube the corners of the x-ray field are under exposed or cut off ~3.5% relative to the light field displayed. anatomy located at the extreme corner(s) of the displayed light field may not be captured on the radiographic image resulting in a potential image retake.


  • Modelo / Serial
    Model Catalog: 5555000 (Lot serial: N/A); Model Catalog: 5555000-2 (Lot serial: N/A); Model Catalog: 5555000-5 (Lot serial: n/a); Model Catalog: 5555000-6 (Lot serial: n/a); Model Catalog: 5555000-3 (Lot serial: n/a); Model Catalog: 5555000-4 (Lot serial: n/a)
  • Descripción del producto
  • Manufacturer