Events

Retiro De Equipo (Recall) de CDAS upgraded Intera MR systems equipped with the Basic Triggering Unit(Full body MRI (Magnetic Resonance Imaging) system)

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-00079-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-02-03
  • 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-00079-1
  • 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
    Philips is informing the customer that the lithium polymer batteries, used in the cdas upgraded intera mr systems equipped with the basic triggering unit may fail after being physically dropped from a height (i.E. from waist height to floor). the failed battery may momentarily produce a flame and then emit smoke, which could lead to a thermal burn to patient or operator in close proximity to the battery. the failure of the battery may occur instantly or may be delayed for a short period of time.
  • Acción
    Philips is providing guidelines to reduce the risk of the battery failure as well as instructions to mitigate the risk of harm in case the battery was dropped. Philips is replacing the affected batteries free of charge. This action has been closed-out on 03/08/2016.

Device

CDAS upgraded Intera MR systems equipped with the Basic Triggering Unit(Full body MRI (Magnetic R...
  • Modelo / Serial
    CDAS upgraded Intera MR systems equipped with the Basic Triggering Unit(Full body MRI (Magnetic Resonance Imaging) system)Part numbers: 9065 and 9067Units Affected: All batteries with date codes 2808 or earlierARTG Number: 98887
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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