Retiro De Equipo (Recall) de GE Carescape B650 Patient Monitor

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por GE Healthcare Finland Oy.

¿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
  • ID del evento
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
  • Causa
    The manufacturer advises there are several potential issues with this device;, 1/ the spo2 saturation limit alartm does not always active with the nellcor spo2, 2/ the device may enter into a constant reboot loop causing the monitor to reboot continuously., 3/ the device may reboot when connected to the unity id, 4/ the device may not update the software for power management card., 5/ an insecurely connected or faulty usb cable may cause the monitor to reboot., 6/ there may be printing delays with the prn50 printer, 7/ the device may reboot due to an x server freeze.
  • Acción
    Software to be upgraded