Events

Retiro De Equipo (Recall) de Extended Brilliance Workstation with running software versions 4.0.2, V4.5.2 or V4.5.3 (To perform offline measurement and manipulation of CT images, diagnostic X-ray system)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Philips Electronics Australia 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-2012-RN-01103-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2012-10-30
  • 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-2012-RN-01103-1
  • 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
    1. when translating the calcium scoring (cs) results into chinese, the percentile is not reported accurately. 2. in the calcium scoring protocol, the protocol is switched to mass score but the protocol name remains agatston.3. spline measurement values do not update when adding control point (cp) and when changing the length of the line. 4. in the ct viewer (ctv) pet studies being loaded from remote with slope different than 1, appear incorrectly in 2d scene and are not displayed with the correct cuv values. 5. loading pet images in the ct viewer (ctv) / quick review from remote with slope different than 1, the images with the different slope appear incorrectly with wrong suv values in perception and in qr.
  • Acción
    Philips is providing work around instructions for each issue and will be implementing a software update to correct the problem.

Device

Extended Brilliance Workstation with running software versions 4.0.2, V4.5.2 or V4.5.3 (To perfor...
  • Modelo / Serial
    Extended Brilliance Workstation with running software versions 4.0.2, V4.5.2 or V4.5.3 (To perform offline measurement and manipulation of CT images, diagnostic X-ray system)ARTG Number: 119929
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DHTGA