Events

Retiro De Equipo (Recall) de Artiste, Oncor and Primus Digital Linear Accelerators running Control Console software version 13.0.302

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-00284-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-02-28
  • 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-00284-1
  • 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 risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table using the simtec auto field sequence option. the following issues will be addressed in the software update solution "auto field sequence (afs) motion protection”:- risk of collision due to automatic gantry movements in case of lateral table shifts and- unwanted automatic gantry movements in case of table configuration set to “manually” and the movement order to be “table first”.
  • Acción
    Siemens is advising affected users to be aware of the updated software solution “Auto Field Sequence (AFS) Motion Protection” which will be implemented at the Control Console of their Digital Linear Accelerator. This software will not execute a movement if a potential collision is anticipated and that users may, in such cases, perform the planned movement manually. Users are further advised that despite these safety measures, there might be scenarios which are not covered by the software. Therefore, during an auto-sequence delivery, users must be aware, at all times, of any movement of the gantry, the treatment table and the applied table offsets or overrides according to the treatment plan.

Device

Artiste, Oncor and Primus Digital Linear Accelerators running Control Console software version 13...
  • Modelo / Serial
    Artiste, Oncor and Primus Digital Linear Accelerators running Control Console software version 13.0.302ARTG Number: 165502
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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