Events

Retiro De Equipo (Recall) de ONCENTRA Brachy version 3.x and 4.x

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Nucletron Pty Limited.

¿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-2015-RN-00448-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-05-27
  • 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-2015-RN-00448-1
  • 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 oncentra brachy (brachy planning (bp) module and plan analysis (pa) module) dose may be incorrectly calculated for regions of interest (rois) defined on a secondary image series when using specific registration methods. the magnitude of the dose calculation error depends on the registration transformation and can vary between 0 and 100% of the correct dose value.
  • Acción
    A software patch is in development to correct this issue and is expected to be released end of November, 2015. Nucletron will work with their customers to implement the patch on affected devices. In the interim, end users are advised to resample Regions of Interest defined on a secondary image series onto the primary image series prior to dose evaluation. This action has been closed-out on 4/08/2016.

Device

ONCENTRA Brachy version 3.x and 4.x

Manufacturer

Nucletron Pty Limited