Events

Retiro De Equipo (Recall) de RaySearch RayStation 3.0 and 3.5 (software versions 3.0.0.251, 3.5.0.16, 3.5.1.6) (Radiation treatment planning and analysis software) Date Manufactured: 15/02/2013

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

¿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-00734-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-07-19
  • 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-00734-1
  • 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
    Under certain conditions resampling of regions of interest (roi) geometries to the dose grid representation is not correctly calculated, and an additional voxel layer is added incorrectly on the superior side of each roi. the problem is more pronounced for very small roi's, leading to over-estimation of dose maximum and under-estimation of the minimum dose.The above problem also affects dose calculated with material overrides, however this should cause no noticeable impact.
  • Acción
    Emergo are providing work around instructions for users to follow. The issue will be corrected in RayStation software version 4.0 which is due for release in July 2013.

Device

RaySearch RayStation 3.0 and 3.5 (software versions 3.0.0.251, 3.5.0.16, 3.5.1.6) (Radiation trea...
  • Modelo / Serial
    RaySearch RayStation 3.0 and 3.5 (software versions 3.0.0.251, 3.5.0.16, 3.5.1.6) (Radiation treatment planning and analysis software)Date Manufactured: 15/02/2013ARTG Number: 195288
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia