Events

Retiro De Equipo (Recall) de BrightView XCT and BrightView X- upgraded with the XCT Flat Panel Detector (Gamma camera)

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-2014-RN-00682-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-06-27
  • 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-2014-RN-00682-1
  • 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
    During a daily xct quality assurance phantom scan for image quality and hounsfield unit (hu) linearity an operator experienced resistance when engaging the locking handle of the fpd in the deployed position. with the locking handle in the locked position, the flat panel detector (fpd) locking mechanism was not locked, moved unexpectedly and contacted the imaging detector during system movement. philips’ investigation determined that the internal linkage shaft broke preventing the fpd from being locked into its correct deployed position.
  • Acción
    Philips Healthcare Field Service Engineers will undertake a field corrective action to ensure no unexpected movement of the Flat Panel Detector. Philips is advising their customers to cease use of the XCT Flat Panel Detector until the implementation of the field corrective action. This action has been closed-out on 18/02/2016.

Device

BrightView XCT and BrightView X- upgraded with the XCT Flat Panel Detector (Gamma camera)
  • Modelo / Serial
    BrightView XCT and BrightView X- upgraded with the XCT Flat Panel Detector (Gamma camera)ARTG Number: 117440
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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