Events

Retiro De Equipo (Recall) de Philips BrightView XCT and Philips BrightView X to XCT Upgrade Kit

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-2017-RN-00210-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2017-02-09
  • 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-2017-RN-00210-1
  • 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
    It has been identified that the intended use statement listed in the instructions for use (ifu) is stated incorrectly. a revision of the ifu with amendments (specifically regarding the functional capabilities of the system) will be released. the amended intended use in the ifu is as follows:brightview xct is a gamma camera for single photon emission computed tomography (spect) and integrates with an attenuation device consisting of flat panel x-ray imaging components. brightview xct produces non-attenuation corrected spect images and attenuation corrected spect images with x-ray transmission data that may also be used for scatter correction. the nuclear medical images and brightview xct images may be registered and displayed in a fused format (overlaid in the same orientation) to provide anatomical localisation of the nuclear medicine data. the brightview xct imaging system should be used only by trained healthcare professionals.
  • Acción
    Philips is advising users to be aware of the updated "Intended Use Statement" highlighted in the Customer Information Letter Users are further advised to continue using the system according to their training.

Device

Philips BrightView XCT and Philips BrightView X to XCT Upgrade Kit
  • Modelo / Serial
    Philips BrightView XCT and Philips BrightView X to XCT Upgrade KitModel Numbers: 882482 and 882454All software versionsARTG Number: 117440
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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