Events

Retiro De Equipo (Recall) de DISCOVERY NM/CT 670 SYSTEM - NM GANTRY

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
    120279
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2013-07-04
  • 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
    Ge healthcare became aware of an incident associated with patient death due to injuries sustained while being scanned on an infinia hawkeye 4 due to a portion of the system falling onto the patient during the scan. gehc has been able to determine the cause of this incident. bolts securing the camera to the gantry were loose thereby stressing the support mechanism and resulting in the incident. the safety concern is related to a potential patient entrapment or crush hazard if the camera falls during a patient exam. gehc has been able to determine the cause of this incident. bolts securing the camera to the gantry were loose thereby stressing the support mechanism and resulting in the incident. the safety concern is related to a potential patient entrapment or crush hazard if the camera falls during a patient exam.

Device

DISCOVERY NM/CT 670 SYSTEM - NM GANTRY
  • Modelo / Serial
    Model Catalog: 5376204-XX (Lot serial: >10 lot numbers contact mfg); Model Catalog: H3100RC (Lot serial: 00000000022051); Model Catalog: H3000YA (Lot serial: > 10 lot numbers contact mfg); Model Catalog: H3000WC/WD (Lot serial: > 10 lot numbers contact mfg); Model Catalog: H3000WW (Lot serial: > 10 lot numbers contact mfg); Model Catalog: H3000WT (Lot serial: > 10 lot numbers contact mfg)
  • Clasificación del producto
    Radiology Devices
  • Descripción del producto
    DISCOVERY NM/CT 670 SYSTEM
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)