Events

Retiro De Equipo (Recall) de DISCOVERY IGS 740 - 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
    36798
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-04-20
  • 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 following issue is being addressed by ge healthcare file no. fmi 12246: ge healthcare has recently become aware of a potential safety issue related to a non-recoverable loss of image acquisition. the affected discovery systems may experience multiple x-ray abort errors during a real-time interventional procedure. this issue could potentially happen before or during a fluoroscopic interventional procedure. there have been no injuries reported as a result of this issue.

Device

DISCOVERY IGS 740 - MAIN UNIT
  • Modelo / Serial
    Model Catalog: 5418813 (Lot serial: 0000HXED001318); Model Catalog: 5418813 (Lot serial: 0000HXED001317); Model Catalog: 5418813 (Lot serial: 0000HXED001320); Model Catalog: 5418812 (Lot serial: 0000HXE9001292)
  • Descripción del producto
    DISCOVERY IGS 740;DISCOVERY IGS 730 SYSTEM
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)