Events

Retiro De Equipo (Recall) de DIRECTVIEW Software versions 5.6 & greater and 5.7 with DR LLI Auto Stitch option on DRX Evolution with Premium and Full Featured Wall Stands(Digital 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-2015-RN-00763-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-08-21
  • 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-2015-RN-00763-1
  • 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 has identified a software issue that impacts image alignment when using the automatic stitching option for long length images. if there is no use of external fiducial markers or measurement tools (eg. radiopaque ruler) when building a composite image and the technologist relies solely on the auto stitching software, there is a risk of undetected stitching errors. this may lead to potential diagnosis errors if measurements taken from just that image wererelied on. any injury resulting from this could lead to delays in treatment or the need for further diagnostic imaging techniques.
  • Acción
    Whilst there have not been any diagnosis errors reported, Carestream Health is conducting this action to update the software on affected devices to correct this issue. In the interim, Carestream Health recommends that the auto-stitching feature is turned off and the manual stitch editor used to create all composite images until the software update has been made to affected devices. This action has been closed-out on 12/08/2016.

Device

DIRECTVIEW Software versions 5.6 & greater and 5.7 with DR LLI Auto Stitch option on DRX Evolutio...
  • Modelo / Serial
    DIRECTVIEW Software versions 5.6 & greater and 5.7 with DR LLI Auto Stitch option on DRX Evolution with Premium and Full Featured Wall Stands(Digital X-ray system)ARTG number: 136112
  • Manufacturer
    Carestream Health Australia Pty Ltd

Manufacturer

Carestream Health Australia Pty Ltd