Events

Retiro De Equipo (Recall) de Invivo Expression MRI Patient Monitoring System - Product 865214

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Philips Electronics Australia 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-2015-RN-00597-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-07-02
  • 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-2015-RN-00597-1
  • 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 device's labelling inaccurately indicates “endotracheal” as a body temperature application site. the flextemp reusable temperature sensor is not intended to be used for endotracheal site placement.
  • Acción
    Philips is advising end users that the FlexTEMP reusable temperature sensor cannot be in endotracheal site. Philips is working to correct this labelling issue and will contact customers with an update on its implementation plan. This action has been closed-out on 09/08/2016.

Device

Invivo Expression MRI Patient Monitoring System - Product 865214
  • Modelo / Serial
    Invivo Expression MRI Patient Monitoring System - Product 865214Units Affected - Devices with the FlexTEMP reusable temperature option installed (serial number range US31204918 - US42708744). Please note that not every serial number within the listed range has the temperature option. Devices without the temperature option are not affected by this medical device correction.ARTG Number: 189095
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DHTGA