Events

Retiro De Equipo (Recall) de AVOXimeter System (a whole blood oximeter used during heart catheterisation procedures)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Zoll Medical Australia 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-00618-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-05-12
  • 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-00618-1
  • 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
    The manufacturer, accriva diagnostics has confirmed that some avoximeter 1000e instruments shipped to customers from july 2015 and april 2016 may have been sent to customers with the diagnostic mode enabled. with the diagnostic mode enabled, users could mistakenly unlock features in the instrument software through a specific sequence of keystrokes. if these features are altered, there is a potential for erroneous results to be displayed. to date accriva has not received any reports of injuries or harm to users due to this issue. instruments in diagnostic mode perform per accriva’s specifications and all data generation is equivalent to those instruments properly set to user mode.
  • Acción
    Zoll Medical is providing instructions for users to be able to identify the affected instruments. In the case where an affected instrument is identified, users should contact Zoll Technical Services to correct the settings. This action has been closed-out on 03/02/2017.

Device

AVOXimeter System (a whole blood oximeter used during heart catheterisation procedures)
  • Modelo / Serial
    AVOXimeter System (a whole blood oximeter used during heart catheterisation procedures)Product Code: AVOX1000ESerial Numbers: 5696-5725, 5816-5977ARTG Number: 262420
  • Manufacturer
    Zoll Medical Australia Pty Ltd

Manufacturer

Zoll Medical Australia Pty Ltd