Events

Retiro De Equipo (Recall) de Clinac, Trilogy, Novalis Tx and Unique linear accelerators (Intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumours and other conditions requiring radiation therapy)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Varian Medical Systems Australasia 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-2012-RN-00852-3
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2012-08-21
  • 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-2012-RN-00852-3
  • 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
    Varian is notifying customers of an anomaly identified with the clinac, trilogy, novalis tx and unique jaw carriers. some jaw carriers were manufactured with the incorrect metal alloy, which can potentially cause the jaw carrier to crack. if both jaw carriers on the same x-jaw were to crack, the jaw would be able to move freely in the closed direction. in this case, the deviation of the jaw position will not be detected by the position readout interlock circuitry. treatment after such a failure occurs may lead to an under-dose of the intended target volume.
  • Acción
    Onsite inspection and replacement of jaw carriers. This action has been closed-out on 18/02/2016.

Device

Clinac, Trilogy, Novalis Tx and Unique linear accelerators (Intended to provide stereotactic radi...
  • Modelo / Serial
    Clinac, Trilogy, Novalis Tx and Unique linear accelerators (Intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumours and other conditions requiring radiation therapy)Product codes: H14, H18, H29Affected Serial Numbers: H140865, H140898, H140899 and H294667ARTG Number: 116839
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    Varian Medical Systems Australasia Pty Ltd

Manufacturer

Varian Medical Systems Australasia Pty Ltd