Events

Retiro De Equipo (Recall) de BrightView XCT(SPECT/CT diagnostic imaging system)

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-2013-RN-00944-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-09-06
  • 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-2013-RN-00944-1
  • 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 received a report from the field that the flat panel detector (fpd) sensor reported to the operator that the panel was unlatched at the 0 degree position during setup. the operator attempted to manually relatch the fpd as it remained in the 0 degree position. in trying to restow the fpd, it fell from its stowed position and contacted the patient's leg and the technologist's arm.
  • Acción
    Philips Healthcare is advising their customers to only deploy or stow the FPD when in the +90 degrees position. Philips will be implementing a field correction to prevent the issue from occurring.

Device

BrightView XCT(SPECT/CT diagnostic imaging system)

Manufacturer

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