Events

Retiro De Equipo (Recall) de Flex Large 4 Coil for MAGNETOM Skyra, Verio, Spectra and Biograph mMR (Full body MRI 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 Siemens 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-2012-RN-00949-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-09-14
  • 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-2012-RN-00949-1
  • 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
    When positioning the coil off centre in the left direction as it is used, for example, a hip and shoulder imaging and, in addition at an off centre position with respect to the head-foot direction, the coil can heat up on the area of the electronic housing (white plastic lids).To be more precise, heating may occur if each of the following conditions applies at the same time:- coil positioned off-center in head-foot direction by more than 5cm- coil at side position- application of higher rf power over several minutes.In that position, the surface temperature may well exceed temperatures defined by regulatory standards and may cause local burns to the patient.
  • Acción
    Siemens is providing work around instructions for users to follow.

Device

Flex Large 4 Coil for MAGNETOM Skyra, Verio, Spectra and Biograph mMR (Full body MRI System)
  • Modelo / Serial
    Flex Large 4 Coil for MAGNETOM Skyra, Verio, Spectra and Biograph mMR (Full body MRI System)ARTG Number: 98485
  • Manufacturer
    Siemens Ltd

Manufacturer

Siemens Ltd
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA