Events

Retiro De Equipo (Recall) de Kodak DirectView DR 7500 System with software version 5.3 (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-00031-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-01-17
  • 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-00031-1
  • 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
    There were two incidents in the united states where the previous patient image was displayed on the console with the current patient's name. carestream health has determined that this only occurs when the user interrupts the daily offset refresh detector calibration by switching the active detector from one bucky to another (e.G. table to the wall) and cancels detector calibration within 30 seconds of initiating this process. there have been no reports of misdiagnosis or injuries related to this issue.
  • Acción
    Carestream Health is recommending that the daily detector calibration process should not be interrupted once initiated and completed only when patients are not being imaged. Carestream Health is installing the software modification as a permanent correction.

Device

Kodak DirectView DR 7500 System with software version 5.3 (diagnostic x-ray system)

Manufacturer

Carestream Health Australia Pty Ltd