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-2017-RN-00085-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-01-24
  • 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-00085-1
  • 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 of unintended motion of a drx revolution mobile x-ray system caused by a loose pivot screw in the drive handle. there was no resulting injury. no other reports of this type have been received since the device was introduced into commercial distribution in 2009, however this problem could manifest itself in additional units over the lifetime of the device. if this failure was to recur in the field, the likelihood of injury would be mitigated by both bump stop and estop systems on the device – which the driver/operator could use. however, given the weight of the device and the speed at which it can travel, should the device make contact with a person, the subsequent collision or crushing injury could be serious e.G. fractured/broken bones.
  • Acción
    Carestream is advising users that they will be inspecting affected serial numbers and replacing the lower handle assembly and internal side covers of the device. In the interim, the device can continue to be used; however it is recommended that routine user inspections of the drive are continued and should any part show a visual problem or fail to operate as expected, the device should be removed from use and a service call placed to Carestream. This action has been closed-out on 01/03/2018.

Device

DRX Revolution Mobile X-Ray System

Manufacturer

Carestream Health Australia Pty Ltd