Events

Retiro De Equipo (Recall) de Masimo Rad-8 Pulse Oximeters Manufactured from March 27, 2009 to January 24, 2013

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Masimo 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-2013-RN-00379-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-04-30
  • 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-2013-RN-00379-1
  • 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
    Masimo has identified a very small number of rad-8 devices that, when moved, can power off without the operator pressing the power button. if a change in power status goes unnoticed by the caretaker, a delay of care could result.This recall action was not notified to the tga before it was initiated by masimo australia.
  • Acción
    Masimo is providing two options to the customers for correction and removal. The first option is to return the Rad-8 devices for Masimo for repair. The second option is for a biomedical engineer employed by a customer to repair the device in the field once qualified by Masimo to do so. This action has been closed-out on 11/02/2016.

Device

Masimo Rad-8 Pulse Oximeters Manufactured from March 27, 2009 to January 24, 2013
  • Modelo / Serial
    Masimo Rad-8 Pulse Oximeters Manufactured from March 27, 2009 to January 24, 2013Device Identifiers: 1844, 1959, 1961, 1963, 22042, 22595, 3446, 9019, 9049, 9073, 9165, 9174, 9190, 9212, 9224,1845, 1960, 1962, 1964, 9020, 9050, 9074, 9166, 9175, 9191, 9213, 9192, 9194, 9193, 9195ARTG Number: 138873
  • Manufacturer
    Masimo Australia Pty Ltd

Manufacturer

Masimo Australia Pty Ltd