Events

Retiro De Equipo (Recall) de Brilliance CT and Ingenuity CT systems with software version v4.1.3 and v4.1.4

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-00637-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2016-05-13
  • 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-00637-1
  • 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
    On the affected ct systems and software versions, varian rpm drive is not mapped in ct user profile after logout/login. the map drive utility maps the varian drive using full varian credentials in the service login and then creates a script that maps it with full varian credentials in the ct user login. once the script has run in the ct login and the user acknowledges the drive mapped successfully, the script deletes itself. on subsequent logins, the drive will not connect because the varian credentials are no longer available. should this situation occur, the user will be unable to perform pulmonary gated scans.
  • Acción
    Philips is advising users to contact Service to login to service mode to reconnect Varian RPM drive. Philips is implementing a software upgrade as a permanent correction. This action has been closed out on 15 June 2017.

Device

Brilliance CT and Ingenuity CT systems with software version v4.1.3 and v4.1.4

Manufacturer

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