Events

Retiro De Equipo (Recall) de ARTISTE, ONCOR and PRIMUS Digital Linear Accelerators Serial numbers equal to or higher than 3094

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-00168-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-02-03
  • 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-00168-1
  • 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 have identified that incorrect values for the rotational collimator position may be displayed due to mechanical problems of the sensor slide. this can happen if the slide, on which the sensors used to detect the rotational collimator position are mounted, is not in its fully latched position. if the user is not aware of the incorrect values the patient can be mistreated by dose at the wrong location.Siemens were also made aware of a defective weld seam at overhead suspensions. due to such a defect the weld seam might break and the overhead suspension might fall down. this can lead to a severe injury of the patient or any other person.
  • Acción
    Siemens is undertaking hardware updates regarding the collimator position detection and improper weld seam at overhead suspensions. To keep the sensor slide in its latched position, a locking plate will be mounted to the sensor slide. This will significantly reduce the risk that the sensor slide might be mechanically misaligned and cause incorrect values being displayed for the rotational collimator position. As reinforcement, a bracket will be added to the overhead suspension to ensure the stability of the connection. This will prevent the overhead suspension from falling down.

Device

ARTISTE, ONCOR and PRIMUS Digital Linear Accelerators Serial numbers equal to or higher than 3094
  • Modelo / Serial
    ARTISTE, ONCOR and PRIMUS Digital Linear Accelerators Serial numbers equal to or higher than 3094ARTG Number: 165502
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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