Events

Retiro De Equipo (Recall) de Syngo X-Workplace with software version VD10E (image processing workstation used with x-ray based diagnostic 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 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-00267-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-03-09
  • 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-00267-1
  • 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
    An issue can occur after the export of segmentation results of the left atrium created on syngo x workplace to an electro-anatomical 3d mapping carto system. after importing, the segmentation result appears mirrored at the carto system, and can't be used for the ablation procedure. although unlikely, there is a risk of serious health effects if the incorrect image is used for ablation.
  • Acción
    Siemens is advising users that a software upgrade will be performed as a permanent correction. Users are advised to stop using any segmentation result for export to the CARTO system until the software upgrade is performed. This action has been closed-out on 25/01/2017.

Device

Syngo X-Workplace with software version VD10E (image processing workstation used with x-ray based...
  • Modelo / Serial
    Syngo X-Workplace with software version VD10E (image processing workstation used with x-ray based diagnostic imaging system)Catalogue Numbers: 10094165, 10281299 and 10502522 when used in combination with CARTO systemsARTG Number: 160940
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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