Events

Retiro De Equipo (Recall) de Allura Xper FD10 F and Allura FD10/10 (diagnostic, fluoroscopic 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-2013-RN-00813-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-08-05
  • 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-00813-1
  • 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
    While the c-arc base rotation is moved manually and at the same time a motorised base rotation is initiated followed by a movement stop request the geometry of the system will reset. consequently the stand movements and table movements then will not be available for about 90 seconds. the table top will be free floating and can manually be moved in both longitudinal and transversal direction.
  • Acción
    Philips is advising users not to initiate a motorised movement of the base rotation when it is moved manually. The system sees this as a conflict and will perform a Geo reset. A software update will be available in Quarter 4 2013.

Device

Allura Xper FD10 F and Allura FD10/10 (diagnostic, fluoroscopic x-ray system)
  • Modelo / Serial
    Allura Xper FD10 F and Allura FD10/10 (diagnostic, fluoroscopic x-ray system) Product Codes: 733001, 722002, 722003, 722005, 722010, 722011, 722014, 722019, 722123 & 722133ARTG Number: 98560
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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