Events

Retiro De Equipo (Recall) de Barco Surgical Displays

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Barco Systems Pty 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-00512-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-06-22
  • 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-00512-1
  • 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 surgical display types listed above could lose the user- defined settings, including failover, under the following condition:after being in stand-by mode or being in autosearch mode for at least an accumulative time of 4,152 hours (173 calendar days) and the unit is powered off and back on, or went into stand-by mode and back on. the accumulative time does not need to be continuous. one of the lost settings is the user setting for automatic failover switching.Barco has investigated this behaviour and confirms that both the failover mode and user (defined) profile settings will indeed be lost on the products involved. however, the factory settings are never lost.The behaviour is caused by a firmware issue on the barco surgical displays listed below.
  • Acción
    As a short term solution Barco is recommending that end users either: - Verify the correctness of the failover mode setting in the user settings before each use; or - Disable the failover mode in the user settings of the OSD and if needed switch manually to the backup source. With this intermediate fix, the display can continue its normal operation, until the final corrective action will be implemented. Barco is currently validating a new firmware version which will fix the issue. This action has been closed-out on 22/08/2016.

Device

Barco Surgical Displays
  • Modelo / Serial
    Barco Surgical DisplaysSurgical Display MDSC-2224 (24 inch) Part Numbers K9307912, K9307913, K9307916 and K9307917Surgical Display MDSC-2226 (26 inch) Part Numbers K9307906, K9307907 and K9307908Surgical Display MDSC-2242 (42 inch) Part Numbers K9307914 and K9307915
  • Manufacturer
    Barco Systems Pty Ltd

Manufacturer

Barco Systems Pty Ltd
  • Empresa matriz del fabricante (2017)
    Barco NV
  • Source
    DHTGA