Events

Retiro De Equipo (Recall) de All Magnetom MRI systems with superconductive magnets

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 Healthcare 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-2015-RN-01251-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-12-22
  • 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-01251-1
  • 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
    In some cases the quench lines of some superconducting magnets may not have been properly installed.Quench lines are installed to vent helium gas in the event of a quench (i.E., sudden loss of superconductivity when the temperature is raised). in the unlikely event that a quench were to occur, a damaged/inappropriately installed quench line could lead to a displacement of oxygen, cold burns and/or could pose a risk to users, patients or others if the helium gas is vented to a closed area inside a building.
  • Acción
    The sponsor is advising users to contact their contract quench line installer (Siemens or third party) to perform a quench line inspection. In the interim, users are reminded that it is important to follow the guidelines outlined in the System Owner Manual, including ensuring that they have an emergency plan in place in the event helium gas escapes into the magnet room or other rooms. This action has been closed-out on 04/05/2017.

Device

All Magnetom MRI systems with superconductive magnets
  • Modelo / Serial
    All Magnetom MRI systems with superconductive magnetsVarious System NamesCatalogue Numbers: 10433372, 10432914, 7391167, 10849579, 10018165, 10352127, 10836666, 10836618, 10849582, 10849583, 10432915, 10849580, 7104719, 10655588, 7104594, 106557, 10018223, 7387074, 10018221 and 10276755ARTG Numbers: 98319, 144221, 98485, 154128 and 188470
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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