Retiro De Equipo (Recall) de Allura Systems: FD10, FD20, FD10/10, Allura Systems with OR table: FD10, FD10/10, FD20/20 (Fluoroscopic x-ray systems used for diagnostic/interventional procedures in cardiovascular and vascular imaging applications)

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-00588-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-06-12
  • País del evento
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
  • 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 received reports of occurrences where the monitor ceiling suspension (mcs) system fell to its lowest position due to an assembly error of the mcs actuator. in one occasion it collided with the table top.
  • Acción
    Philips Healthcare is issuing work around instructions as a temporary measure. The affected MCS actuators will be replaced as a permenant fix.

Device

  • Modelo / Serial
    Allura Systems: FD10, FD20, FD10/10, Allura Systems with OR table: FD10, FD10/10, FD20/20 (Fluoroscopic x-ray systems used for diagnostic/interventional procedures in cardiovascular and vascular imaging applications)Product codes: 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023, 722024, 722025Applies to:Actuator Short Assy: 989600-184-665Actuator Long Assy: 989600-184-654ARTG number: 98560, 175708
  • Manufacturer

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    DHTGA