Events

Retiro De Equipo (Recall) de Carestream DRX Evolution with Full Featured Wall Stand, Carestream DRX Evolution with Carestream Premium Wall Stand and Kodak DirectView DR 7500 System with Full FeaturedWall Stand

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-01285-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-12-04
  • 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-2013-RN-01285-1
  • 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 advice that there were three incidents (one in australia and two in the united states) where the wall stand (bucky) continued its downward movement despite the radiographer/operator releasing the motorised wall stand (ws) keypad button which controls the downward movement. this can result in the wall stand contacting a patient's legs or feet.
  • Acción
    Carestream Australia is conducting a field action to apply a label to remind users of the location of the emergency stop button and to inspect and install a bracing bracket for the motorised wall stand (bucky) keypad or replace keypad if deemed necessary by Carestream's service engineer.

Device

Carestream DRX Evolution with Full Featured Wall Stand, Carestream DRX Evolution with Carestream ...
  • Modelo / Serial
    Carestream DRX Evolution with Full Featured Wall Stand, Carestream DRX Evolution with Carestream Premium Wall Stand and Kodak DirectView DR 7500 System with Full FeaturedWall StandSerial numbers: 4000 – 5160 and 75000103 - 75000944ARTG number: 136112
  • Manufacturer
    Carestream Health Australia Pty Ltd

Manufacturer

Carestream Health Australia Pty Ltd