Events

Retiro De Equipo (Recall) de Samsung Digital X-Ray System GC80

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-2018-RN-00671-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-06-14
  • 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-2018-RN-00671-1
  • 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
    Two issues have been identified with the samsung digital x-ray system gc80:1. if the user does not completely close the detector tray in the table or stand, the system turns into the portable mode or the multi-portable mode and auto exposure control (aec) turns off. at this time, the screen of workstation and the screen of tube head unit (thu) show the portable mode on or the multi portable mode on and aec off. if the user makes an exposure without checking, it may be irradiated differently than intended and produce an unintended image.2. if the user incorrectly attempts to use a portable detector within the table detector or stand detector areas with the auto detector option switched on, the system may automatically select the table or stand detectors if the focal spot is met. in this situation, if the user attempts an exposure of the portable detector without checking which detector is selected, it may be irradiated differently than intended and produce an unintended image.
  • Acción
    Samsung is advising users: 1. Carefully close the detector tray and check that the detector tray is completely closed. 2. When using a portable detector: a. ensure the portable detector is placed outside the table detector or stand detector area when the auto detector option is switched on; or b. switch off the auto detector option before exposing patients with a portable detector placed within the table or stand detector areas. 3. Always carefully check the screen of Workstation or the screen of THU before making an exposure, and be sure to check the Receptor (4), AEC mode (7,8), and the exposure condition (1,2,3,5,6,9,10,11,12). If the intended detector is not set, please select the detector to be used. Samsung is planning to release updated software (expected to be available 30 June 2018) to prevent the outlined issues occurring. Implementation of the software update will be carried out by Quantum Healthcare Pty Ltd.

Device

Samsung Digital X-Ray System GC80
  • Modelo / Serial
    Samsung Digital X-Ray System GC80ARTG Number: 224370(Samsung Electronics Australia - X-ray system, diagnostic, general-purpose, stationary, digital)
  • Manufacturer
    Samsung Electronics Australia Pty Ltd

Manufacturer

Samsung Electronics Australia Pty Ltd