Events

Retiro De Equipo (Recall) de MX 16-slice CT x-ray systems with software version v1.1.4.21426.

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-00616-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-05-12
  • 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-00616-1
  • 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
    The following issues have been found in mx 16-slice systems.1) during the filming operation, the clipboard used for copying and pasting images is not cleared between patients. if the operator fails to copy the current patient’s images before pasting, a previous patient’s images may be present in the clipboard and be copied onto the film of the current patient. 2) during the bolus tracking scan, if the auto voice in tracker scan is enabled, the tracker scan will be aborted unexpectedly and the diagnostic scan after the tracker scan needs to be manually started.3) if the scan protocol with sas (spiral auto start) function is selected to plan the scan, the sas option may not be displayed on the contrast tab of the scan protocol parameter area or the sas option is displayed but not enabled as pre-configured in the protocol. this issue only occurs on the first helical scan after system startup that applies sas function.There have been no reports of injuries.
  • Acción
    Philips is providing users with work around instructions to follow as an interim measure. A software upgrade will be implemented as a permanent correction. This action has been closed-out on 02/03/2017.

Device

MX 16-slice CT x-ray systems with software version v1.1.4.21426.

Manufacturer

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