Events

Retiro De Equipo (Recall) de GC80 Diagnostic 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 Samsung Electronics Australia 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-2017-RN-00653-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-06-13
  • 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-2017-RN-00653-1
  • 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
    An incident had been reported in germany to samsung electronics on 15 dec 2016 where an image was obtained with over exposure during a thorax examination using the aec function. the exposure condition was: 125kv, 180mas.As a result of the malfunction of the aec, irradiation may not terminate properly which can cause exposure until the aec back up time which is set at 500msec by default. this can cause overexposure for users.
  • Acción
    Samsung will be implementing a software update on affected units in early July 2017. In the interim, users are advised that they may continue to use the GC80 system, taking precaution of any possible network disconnection between the THU and WS. Users are requested to check 1) the THU connection status when using the system and 2) the THU connection before logging in after system booting. (Please refer to recall notification for images and further details).

Device

GC80 Diagnostic X-Ray system

Manufacturer

Samsung Electronics Australia Pty Ltd