Events

Retiro De Equipo (Recall) de Philips Brilliance 16-Slice (Air), Brilliance 64 CT, Ingenuity Core, Ingenuity Core 128, Brilliance CT Big Bore, Ingenuity Flex. Software versions V3.6.1, V3.6.2, V3.6.4, and V3.6.5 (X-ray system, diagnostic, computed tomography, full-body)

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-2015-RN-00987-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-10-09
  • 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-2015-RN-00987-1
  • 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
    Image position accuracy - image rotation calibration program performed by field service engineer can report pass but fail to produce the correct angular rotation offset value for the ultra-fast scan mode. the inaccurate angular rotation offset can impact the accuracy of radiation treatment planning.Tracker image artefact - tracker scan image of ct angiography (cta) examination can exhibit a streaking artefact. due to the streaking artefact, the automatic clinical scan may be triggered at the wrong time resulting in suboptimal ct diagnostic images that do not capture the bolus peak of the imaged body section.Ring/dot image artefact due to x-ray measurement - after a complete system power shutdown and power up, if a head scan is performed without air calibration and without quick iq check scan after power up, intermittent ring/dot image artifacts in the reconstructed images may occur.
  • Acción
    Philips Healthcare are providing users with work around instructions to follow as an interim measure. A software update will be installed on all affected systems as a permanent correction. This action has been closed-out on 31/08/2016.

Device

Philips Brilliance 16-Slice (Air), Brilliance 64 CT, Ingenuity Core, Ingenuity Core 128, Brillian...
  • Modelo / Serial
    Philips Brilliance 16-Slice (Air), Brilliance 64 CT, Ingenuity Core, Ingenuity Core 128, Brilliance CT Big Bore, Ingenuity Flex. Software versions V3.6.1, V3.6.2, V3.6.4, and V3.6.5 (X-ray system, diagnostic, computed tomography, full-body)ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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