Events

Retiro De Equipo (Recall) de Focal Release 4.80.00

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Elekta 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-01356-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-12-23
  • 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-01356-1
  • 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
    When a ct phantom is scanned and the images are transferred to focal, it is possible to sample the densities using the image statistics tool in focal. in the case where ct slice thickness is not the same as ct slice spacing the image statistics tool will report an incorrect hu. if the user bases their ct to ed file on this incorrect density information, dose calculation errors will result. the magnitude of the dose calculation error will be dependent on the magnitude of the hu error.This problem can only occur for sites who satisfy all of the below criteria:1. running focal release 4.80.00 2. using a ct slice spacing not equal to the ct slice thickness, and3. using the image statistics tool to quantify ct phantom densities which are then used to populate the ct to ed file.There have been no patient injuries reported.
  • Acción
    As an immediate workaround:- The problem can be avoided by using a CT Slice Spacing equal to the CT Slice Thickness; and A software fix will be provided to rectify the defect as soon as possible. This action has been closed-out on 28/02/2018.

Device

Focal Release 4.80.00
  • Modelo / Serial
    Focal Release 4.80.00 ARTG Number: 186853
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

Elekta Pty Ltd
  • Empresa matriz del fabricante (2017)
    Elekta AB
  • Source
    DHTGA