Events

Retiro De Equipo (Recall) de Biograph mCT systems running the VG40A or VG40B software(Digital 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 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-2013-RN-00623-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-06-19
  • 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-2013-RN-00623-1
  • 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
    This recall action is an update to rc-2013-rn-00357-1.Siemens has identified that biograph mct systems running software vg40a or vg40b can experience intermittent aborting of ct or pet/ct scans during an examination, in addition to intermittent ct planning and image reconstruction failures. these issue are due to software errors.
  • Acción
    Siemens is advising end users on how a check can be performed during the planning of the CT acquisitions and reconstructions, within a PET/CT protocol that could indicate that a problem is likely to occur. The problems will be addressed in the upcoming VG40C software release which is planned to be released within the next 2 months.

Device

Biograph mCT systems running the VG40A or VG40B software(Digital Imaging System)
  • Modelo / Serial
    Biograph mCT systems running the VG40A or VG40B software(Digital Imaging System)
  • Manufacturer
    Siemens Ltd

Manufacturer

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