Events

Retiro De Equipo (Recall) de MILLENNIUM VG VARIABLE GEOMETRY DUAL DETECTOR CAMERA

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
    75668
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-02-07
  • 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 has recently become aware of a potential safety issue related to unintended radial detector motion which may occur during patient setup or at the end of a patient scan. this failure mode has been observed on a single system for a whole body scan in which the detector moved to the home position and then slowly started drifting inward toward the patient.

Device

MILLENNIUM VG VARIABLE GEOMETRY DUAL DETECTOR CAMERA
  • Modelo / Serial
    Model Catalog: H3000YA (Lot serial: N/A); Model Catalog: NIL (Lot serial: N/A); Model Catalog: H3000WW (Lot serial: N/A); Model Catalog: H3000WT (Lot serial: N/A); Model Catalog: H3000WC/WD (Lot serial: N/A); Model Catalog: H3000YM (Lot serial: N/A); Model Catalog: H3000WZ (Lot serial: N/A); Model Catalog: H3000YS (Lot serial: N/A)
  • Descripción del producto
    Millennium VG Variable Gemetry Dual Detector Cam
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)