Retiro De Equipo (Recall) de Horizon Medical Imaging (HMI) products software versions 4.5 to and including 11.9 (Radiology picture archiving and communication 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 Device Technologies 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    During the archive procedure, if the system begins to archive images for multiple studies within fractions of a second and an unexpected condition causes the software process restart the following issues may occur:1. incorrect images being displayed for a study retrieved from archive (for example, a study for a different patient being displayed),2. failure to retrieve images for a study from archive.If this issue occurs, two or more studies may be affected. this issue is not immediately evident to the user at the time of archival. it is possible that clinical decisions will be made using an incorrect set of images or an incomplete set of images. this may result in inappropriate care leading to patient harm if unnoticed or a need to retake images.
  • Acción
    Device Technologies is providing users with work around instructions to follow as an interim measure. A software upgrade will be implemented as a permanent correction.