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-2014-RN-01267-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-12-04
  • 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-2014-RN-01267-1
  • 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
    Carestream health australia pty ltd has received a report that an overseas service engineer observed a loose boom arm during routine maintenance on a drx revolution mobile x-ray system as one of three bolts that secure the boom to the carriage had fractured and the other two bolts were loose causing the boom arm to become loose. no other reports of this type have been received since the device was introduced into commercial distribution in 2009.It was determined from the engineering assessment that the bolts installed in this specific carriage were not tightened to the required torque spec which could cause bolt failure due to bending fatigue.
  • Acción
    Carestream Health Australia is arranging for a service visit to affected customers to identify loose booms and replace carriage attachment bolts. This action has been closed-out on 07/06/2016.

Device

DRX Revolution Mobile X-Ray System

Manufacturer

Carestream Health Australia Pty Ltd