Events

Retiro De Equipo (Recall) de Artis zee, Artis Q and Artis Q.zen systems with software version VD11B

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-2016-RN-01637-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-12-20
  • 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-2016-RN-01637-1
  • 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
    During regular field observations siemens have identified a software issue with two possible, mutually independent causes of a system defect, these are as follows:1. in artis systems with a100plus or a100g generators, an attempt to resume operation following detection of a fault (such as a short circuit in the x-ray tube) can result in the failure of a module in the high-voltage generator; and2. for biplane systems delivered with software version vd11b since april of this year, software problems in conjunction with the graphics card may in rare cases result in the loss of image display in the examination room.Siemens advises they do not consider it necessary to re-examine any patients in this case and that this is a possible hardware defect that has no influence on the treatment of patients.A system software update will implement additional protective mechanisms for the generator and correct the software problem.
  • Acción
    Siemens will be contacting affected users to arrange a date to perform a system software update, which will implement additional protective mechanisms for the generator and correct the software problem.

Device

Artis zee, Artis Q and Artis Q.zen systems with software version VD11B
  • Modelo / Serial
    Artis zee, Artis Q and Artis Q.zen systems with software version VD11BCatalogue/Lot Numbers: 10848281, 10848355, 10848282, 10848280, 10094139, 10094137, 10848353ARTG Number: 273952
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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