Events

Retiro De Equipo (Recall) de Brilliance CT 64-Channel with Essence Technology, Ingenuity Core, Ingenuity Core128 and Ingenuity CT, software versions v4.1.3, v4.1.4 and 4.1.5 (used for diagnostic computed tomography scanning)

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-2016-RN-00576-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-05-12
  • 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-2016-RN-00576-1
  • 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
    The following issues have been identified which may result in additional patient scanning and threfore additional radiation doses. there have been no reports of injuries as a result of these issues;- sagittal result shortened for axial head scans.- when axial images are acquired with a gantry tilt, the scan increment is manually changed to the same value as the collimation, the console viewer will not allow creation of mpr images due to the scan series being broken into serval series of images.- scan length changes with a change in field of view (fov).- scan length changes on subsequent axial results.- surview scan lengths near 184.4mm & 135.0mm may result in unexpected scan start positions.- there may be a discrepancy between the calculated reconstruction length and the actual scan length which may result in the inability to reconstruct the raw data. offline reconstruction of the raw data is not possible.
  • Acción
    Philips is providing work around instructions for users to follow as an interim measure. A software upgrade will be implemented as a permanent correction.

Device

Brilliance CT 64-Channel with Essence Technology, Ingenuity Core, Ingenuity Core128 and Ingenuity...
  • Modelo / Serial
    Brilliance CT 64-Channel with Essence Technology, Ingenuity Core, Ingenuity Core128 and Ingenuity CT, software versions v4.1.3, v4.1.4 and 4.1.5 (used for diagnostic computed tomography scanning)ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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