Events

Retiro De Equipo (Recall) de OPTIMA XR220AMX 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
    Recall
  • ID del evento
    25788
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2012-07-20
  • 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
    The service procedure for wheel and caster replacement in the service documentation does not contain sufficient warnings to ensure the service representative has placed the tube into locked position to ensure it does not swing out and change the center of gravity of the unit thus resulting in the unit tipping over. it is also recommended to clear the work area of unnecessary personnel prior to performing this repair. the fall of the system may create a hazard to service personnel.

Device

OPTIMA XR220AMX X-RAY SYSTEM
  • Modelo / Serial
    Model Catalog: 5555000-5 (Lot serial: >10 numbers contact mfg); Model Catalog: 5555000-6 (Lot serial: >10 numbers contact mfg); Model Catalog: 5555000 (Lot serial: >10 numbers contact mfg); Model Catalog: 5555000-2 (Lot serial: >10 numbers contact mfg); Model Catalog: 5555000-4 (Lot serial: 00001027061WK9); Model Catalog: 5555000-3 (Lot serial: 00001027061WK9); Model Catalog: 5555000-4 (Lot serial: 00001028024WK6); Model Catalog: 5555000-3 (Lot serial: 00001028024WK6); Model Catalog: 5555000-4 (Lot serial: 00001027893WK5); Model Catalog: 5555000-3 (Lot serial: 00001027893WK5); Model Catalog: 5555000-3 (Lot serial: 00001027195WK5); Model Catalog: 5555000-3 (Lot serial: 00001027826WK5); Model Catalog: 5555000-4 (Lot serial: 00001027300WK1); Model Catalog: 5555000-3 (Lot serial: 00001027300WK1); Model Catalog: 5555000-4 (Lot serial: 00001027263WK1); Model Catalog: 5555000-3 (Lot serial: 00001027263WK1); Model Catalog: 5555000-4 (Lot serial: 00001027195WK5); Model Catalog: 5555000-4 (Lot serial: 00001027826WK5)
  • Descripción del producto
    OPTIMA XR220AMX X-RAY SYSTEM
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)