Events

Retiro De Equipo (Recall) de syngo WorkFlow MLR with version VB30C_FP1, VB30E, VB35A, VB36A and "Portal Radiologist" license (radiology information system used to process data)

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-00303-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-04-05
  • 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-00303-1
  • 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
    If procedures requested have been deleted or changed (eg. because a procedure was replaced by a better fitting one in syngo workflow browser or portal radiologist), and the clinical information (risk factors, lab values, reason, diagnosis) was changed after the procedure was changed, then outdated clinical information (risk factors, lab values, reason, diagnosis) could be displayed in the user interface and saved (reason is that the outdated procedure with the outdated clinical information is used).
  • Acción
    Siemens is providing users with work around instructions to prevent the problem occurring and is also developing a software correction to permanently correct the problem.

Device

syngo WorkFlow MLR with version VB30C_FP1, VB30E, VB35A, VB36A and "Portal Radiologist" license (...
  • Modelo / Serial
    syngo WorkFlow MLR with version VB30C_FP1, VB30E, VB35A, VB36A and "Portal Radiologist" license (radiology information system used to process data)ARTG Number: 184557
  • Manufacturer
    Siemens Ltd

Manufacturer

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