Events

Retiro De Equipo (Recall) de Mobile Digital X-Ray GM60A

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-00391-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-04-20
  • 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-00391-1
  • 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
    Samsung has been notified of an issue of over exposed x- ray images. the investigation revealed that mas value had increased without any interaction of the user even when the correct protocol had been followed by the operator. it's been observed from log files analysis that the mas values had increased during the examination and had showed that patients received different dose values than what was stored in the pre-defined protocols. it is discovered that the touch screen is sensitive to unintended touch which may occur if any liquid/ foreign bodies are on the screen. it had also been identified that in these particular incidents, the tube cable had touched the msec up button when the tube head unit of gm60a was at the parked position. protocols were set before the device had been moved & positioned by the patient. whilst the device was moved, the cable had touched the panel and increased the exposure condition to the maximum value. this may lead to unintended exposure to the patient.
  • Acción
    Samsung has developed a software update which will be implemented by a trained service engineer who will attend the users' premises. In the interim, Samsung is recommending users ensure that the GM60A system is moved into position before parameters are set and that there are no obstructions to the touchscreen which may cause an increase in values during the examination and to always ensure that the correct exposure levels have been set before exposure to the patient.

Device

Mobile Digital X-Ray GM60A

Manufacturer

Samsung Electronics Australia Pty Ltd