Events

Retiro De Equipo (Recall) de OPTIMA XR200AMX X-RAY SYSTEM - MAIN UNIT

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
    Recall
  • ID del evento
    27253
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2012-05-28
  • País del evento
    Canada
  • Fuente del evento
    HC
  • 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
    In some instances the user interface on the system may appear as though it has ceased responding to commands. in this case while the interface may not reflect any of the changes being commanded to the user it is in actuality updating the system computer with the commands requested. this may result in a situation where the user interface indicates a different technique selection than is actually selected on the system. therefore the potential exists for the system to perform a different technique selection for an exposure than may be indicated to the user.

Device

OPTIMA XR200AMX X-RAY SYSTEM - MAIN UNIT
  • Modelo / Serial
    Model Catalog: 5555000-3 (Lot serial: N/A); Model Catalog: 5555000-4 (Lot serial: N/A); Model Catalog: 5555000-5 (Lot serial: N/A); Model Catalog: 5555000-6 (Lot serial: N/A)
  • Descripción del producto
    OPTIMA XR200AMX X-RAY SYSTEM - MAIN UNIT
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)