Events

Retiro De Equipo (Recall) de Kodak DirectView DR 7500 (Diagnostic 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-00839-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-07-31
  • 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-00839-1
  • 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 was an incident overseas where the beta assembly (x-ray tube and collimator) detached from the overhead tube crane (otc) telescope, falling onto the patient who was injured, requiring hospitalisation. no other reports of this type have been received since the device was introduced into commercial distribution in 2005. carestream health has determined that this incident occurred due to the part that holds the beta assembly to the otc telescope not being properly assembled at the time of manufacture.
  • Acción
    Carestream Health Australia Pty Ltd is arranging for inspection of all the affected units and will conduct a repair if required. This action has been closed-out on 19/02/2016.

Device

Kodak DirectView DR 7500 (Diagnostic x-ray system)

Manufacturer

Carestream Health Australia Pty Ltd