Events

Retiro De Equipo (Recall) de Xhibit Central Station, software version 1.1.5

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Ecomed Pty Ltd.

¿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
    RC-2016-RN-01459-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2016-11-16
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01459-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Reports have been received of telemetry spo2 numerics dropping off the xhibit central display when using software version 1.1.5 with connectivity to telemetry. desaturation, high, and low limit alarms work normally. this problem can occur when the xhibit central station software version 1.1.5 is used in conjunction with a telemetry receiver for purposes of remote patient monitoring.Ecomed pty ltd has not supplied any telemetry receiver medical devices to the australian hospitals that are connected to software version 1.1.5 of xhibit central station.
  • Acción
    Although there is no product affected in Australia, product correction is being undertaken by Ecomed Pty Ltd to support potential future use of telemetry functionality with the Xhibit Central System in relevant Australian hospitals. Ecomed will be contacting affected customers to perform a software update. This action has been closed-out 11/05/2017.

Device

Xhibit Central Station, software version 1.1.5
  • Modelo / Serial
    Xhibit Central Station, software version 1.1.5Serial Numbers: SLA1015F00831, SLA0916F02109ARTG Number: 237776
  • Manufacturer
    Ecomed Pty Ltd

Manufacturer

Ecomed Pty Ltd