Events

Retiro De Equipo (Recall) de syngo X-Workplace with software VD10E and tabcard ”4D”Siemens

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-01151-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-12-01
  • 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-01151-1
  • 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
    There is a software related issue with the syngo x-workplace (s/w vd10e) and tabcard "4d" viewer application. when a volume is acquired with a ct scanner with a tilted gantry, the measurements displayed in the 4d tabcard can be incorrect, due to incorrect calculations in the multi-planar reformattings (mprs) of the volume. this might potentially result in the physician selecting a device with the wrong size (too small), which then needs to be exchanged. in the event that the device needs to be exchanged, it could lead to a medium term delay in a clinical procedure.
  • Acción
    The sponsor Siemens will contact the affected customers to arrange for the installation of a software update which will eliminate the reported problem. Users are advised to load the MPR acquired at a CT scanner with tilted gantry into “viewing” application and perform 2d measurements there until the software update has been installed. This action has been closed-out on 29/08/2016.

Device

syngo X-Workplace with software VD10E and tabcard ”4D”Siemens
  • Modelo / Serial
    syngo X-Workplace with software VD10E and tabcard ”4D”Siemens Material Numbers: 105025522 and 10281299ARTG Number: 160941
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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