Events

Retiro De Equipo (Recall) de On-Board Imager (OBI) (used with linear accelerators for verification of correct patient position in relation to isocenter and verification of treatment fields)

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-2014-RN-00363-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-03-26
  • 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-2014-RN-00363-1
  • 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
    In the three known failures, belt over-tensioning caused the motor shaft to fail over time. this over tensioning would have taken place during servicing. this failure permitted the exact arm elbow joint to swing freely with gravity. a message such as "kv detector elbow axis not calibrated" or "kv source elbow axis not calibrated" may appear, or the user may hear a grinding or shearing sound at or before the time of failure. potential injury from the kv source striking a patient is dependent upon the anatomic site being treated and the height of the couch.
  • Acción
    A Varian Medical Systems Customer Support Service representative will arrange a site visit to check the belt tension of the Type 01 elbow motors of all OBI and MV Exact arms. If over-tensioned belts are detected, the elbow motor will be replaced with a Type 02 elbow motor. Until Varian inspects the OBI Exact arms, users should not extend or retract the kV Source arm when it is above a patient. Users should ensure that the gantry is positioned so that the kV Source is lateral to, or underneath, the patient-couch prior to extending or retracting the arm. Sites doing their own servicing or using a third party service provider, must ensure that they are following Varian service instructions. This action has been closed-out on 02/02/2016.

Device

On-Board Imager (OBI) (used with linear accelerators for verification of correct patient position...

Manufacturer

Varian Medical Systems Australasia Pty Ltd