Events

Retiro De Equipo (Recall) de syngo RT Oncologist with software version 4.2.X or 4.3.X (image processing device that can be a component of one or more radiation therapy systems)

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-01087-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-08-18
  • 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-01087-1
  • 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 are advising users regarding a bundled update of the syngo rt oncologist software. the update addresses the following issues:- incorrect offset calculation in adaptive targeting option. in rare cases, an identical region of interest (roi) label for the planning isocenter and the treatment isocenter may have been randomly generated during image processing. in this case the offset calculation in adaptive targeting during image review has been incorrect. - problems with structure name in case of using structure operation functionality in segmentation. in special scenarios within the structure operation functionality of the segmentation tab, the system did not store the selected name from the list of predefined names when creating a new structure. after reloading the data, the system replaced the name of this structure by the name of the former last deleted structure.There have been no reports of injuries as a result of the reported issues.
  • Acción
    Siemens is advising users of the potential issues in order for users to maintain awareness until the software correction is implemented as a permanent correction. This action has been closed out on 16 June 2017.

Device

syngo RT Oncologist with software version 4.2.X or 4.3.X (image processing device that can be a c...
  • Modelo / Serial
    syngo RT Oncologist with software version 4.2.X or 4.3.X (image processing device that can be a component of one or more radiation therapy systems)ARTG Number: 181846
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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