Events

Retiro De Equipo (Recall) de RPM Respiratory Gating System, version v1.7.5 with 3D Option (Patient respiratory monitoring system used with 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 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-2013-RN-00371-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-04-24
  • 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-2013-RN-00371-1
  • 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
    While operating with the 6-dot marker block, this version of rpm gating may produce an inverted respiratory waveform in amplitude and phase-gating sessions. the error may be reproduced if the rpm system is induced to frequently lose and reacquire tracking of the 6-dot marker block during a calibration sequence, a reference session or a single session after tracking has begun.
  • Acción
    Varian is providing temporary work around instructions and is implementing a software update to permanently correct the problem.

Device

RPM Respiratory Gating System, version v1.7.5 with 3D Option (Patient respiratory monitoring syst...
  • Modelo / Serial
    RPM Respiratory Gating System, version v1.7.5 with 3D Option (Patient respiratory monitoring system used with radiation therapy systems) Product code: H50Multiple serial numbers affectedARTG Number: 117951
  • Manufacturer
    Varian Medical Systems Australasia Pty Ltd

Manufacturer

Varian Medical Systems Australasia Pty Ltd