Events

Retiro De Equipo (Recall) de DRX Revolution Mobile 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 Carestream Health 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-2013-RN-01269-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-12-09
  • 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-2013-RN-01269-1
  • 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 manufacturer, carestream health inc has received reports of the below incidents:- in the usa, the end cover of the drx revolution mobile x-ray system column was dislodged when it was caught on an interfering object whilst the column was descending.- four occurrences in the usa of a communication failure between pc (host computer) and communication i/o board (cib) resulting in the generator not being reset after a successful exposure and image acquisition. this resulted in an exposure initiated by the user using the hand switch completing without the image being captured.
  • Acción
    Carestream Health is installing a replacement end cap and software update to correct the issues.

Device

DRX Revolution Mobile X-Ray System

Manufacturer

Carestream Health Australia Pty Ltd