Events

Retiro De Equipo (Recall) de syngo Workflow MLR using Portal Radiologist

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-00854-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-07-11
  • 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-00854-1
  • 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 a potential issue with syngo workflow mlr where reports signed off in portal radiologist are sporadically not transferred to external systems. due to irregular synchronisation issues within an mlr application internal process, it can fail to return the appropriate data. the report will not be shared with external systems however the report content is intact within syngo workflow mlr.
  • Acción
    For the 'Affected versions' of syngo Workflow MLR, a fix of this potential malfunction is in preparation by Siemens Healthcare GmbH via the upcoming syngo Workflow MLR software update version VB37B this issue will be resolved.

Device

syngo Workflow MLR using Portal Radiologist
  • Modelo / Serial
    syngo Workflow MLR using Portal RadiologistSoftware versions: VB30C, VB30E, VB30F, VB35A, VB35B, VB36A and VB37ACatalogue Number: 10014099ARTG Number: 274609
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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