Events

Retiro De Equipo (Recall) de BrightView XCT SPECT/CT systems

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-01226-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-11-20
  • 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-01226-1
  • 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
    Philips has identified two issues with the brightview xct spect/ct systems: 1) whilst performing a clinical spect/ ct study on a brightview xct spect/ct systems, the ct portion of the scan may be interrupted and not complete successfully. this problem is not detectable by the user prior to the interruption of the ct acquisition. interruption of the ct acquisition portion of the scan may necessitate a re-scan of the interrupted segment, resulting in overall radiation to the patient being higher than planned. the additional radiation would be less than the amount delivered from a single successful scan of that body segment.2) investigation of generator faults from the field have identified that the ground connection on the x-ray generator cabinet may have been wired incorrectly during installation.
  • Acción
    Philips is advising users of the issue and providing work around instructions should the problem occur. Philips is also updating the XCT generator configuration to increase tube life and implementing a software update.

Device

BrightView XCT SPECT/CT systems

Manufacturer

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