Events

Retiro De Equipo (Recall) de Allura Xper FD Release 8.2.16(Flouroscopic x-ray used in angiography)

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-2015-RN-00995-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-10-09
  • 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-2015-RN-00995-1
  • 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 discovered through customer feedback and internal testing a software failure that could lead to an intermittent and short term unavailability of the fluoroscopy function. upon initiating fluoroscopy the user may encounter a user message “fluoro failed, please retry” and fluoroscopy will be unavailable. retrying fluoroscopy resolves this situation in most cases. you may need to retry more than once in about 2% of the events.The failure mode has no impact on an active fluoroscopy run. once started, an active fluoroscopy run continues until releasing the pedal.
  • Acción
    Philips is advising end users that they must retry fluoroscopy if the failure mode occurs. Philips Field Service Engineers will install Software R8.2.16.1 which will correct the issue. The expected date of the correction release is October 2015. This action has been closed-out on 26/08/2016.

Device

Allura Xper FD Release 8.2.16(Flouroscopic x-ray used in angiography)

Manufacturer

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