Events

Retiro De Equipo (Recall) de Artis zee and Artis Q systems with software version VD11C

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-2017-RN-01186-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-09-13
  • 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-2017-RN-01186-1
  • 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
    Siemens has identified an issue whereby in the application “dsa roadmap” the artis system's intended behaviour is to reject the stored vesselmap from previously acquired dsa if the patient table was moved during the roadmap workflow. in rare cases the system does not reject the dsa vesselmap and uses it for the further roadmap workflow steps. depending on the amount of table movement which was applied during the roadmap workflow, the dsa vesselmap may be overlaid as vessel tree at a position which does not fulfil siemens' requirements for accuracy.If the displacement of the vessel tree is large, it may be recognised by the user. however, if the displacement is either slight or at an unfavourable plane, the user may rely on incorrect visualisation of the catheter relative to the vesselmap.
  • Acción
    1. The software in affected systems will be updated to correct the issue. 2. Users are to return the supplied acknowledgement form. 3. If the device is no longer in their possession forward the notice to the new owners. 4. Siemens will contact users to arrange a time to perform the software upgrade.

Device

Artis zee and Artis Q systems with software version VD11C
  • Modelo / Serial
    Artis zee and Artis Q systems with software version VD11CCatalogue/Lot Numbers: 10094137, 10848281, 10848282, 10848280, 10848283, 10094135, 10094139, 10848355, 10280959 and 10848353ARTG Number: 273952
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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