Events

Retiro De Equipo (Recall) de Allura Xper with software release FD R8.1.16(Fluoroscopic angiographic x-ray 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-2016-RN-00274-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-03-18
  • 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-00274-1
  • 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 healthcare has identified through customer complaints and internal testing that uncontrolled geometry movements can occur when the system is not switched on/off regularly. due to the nature of the problem, the user will perceive a gradually increased sluggishness. upon activation of the iu controls an uncontrolled geometry movement can occur. the uncontrolled movements are immediately stopped upon release of the iu controls. all safety measures such as current sensing, 3d model and bodyguard remain intact avoiding serious harm to patient and bystander. a system reboot will restore normal system operation.
  • Acción
    Philips is advising users to regularly restart the system as per the Instructions for Use (IFU) once a day to avoid uncontrolled movements. A software update will be provided as a permanent fix. This action has been closed-out on 26/05/2017.

Device

Allura Xper with software release FD R8.1.16(Fluoroscopic angiographic x-ray system)
  • Modelo / Serial
    Allura Xper with software release FD R8.1.16(Fluoroscopic angiographic x-ray system)ARTG Number: 175708
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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