Events

Retiro De Equipo (Recall) de Horizon Medical Imaging products versions 4.5 up to and including 11.9 and McKesson Radiology 12.0 (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
    Recall
  • ID del evento
    RC-2014-RN-00610-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-06-03
  • 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-00610-1
  • 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
    The manufacturer, mckesson has identified a software issue which may cause a discrepancy between the index of images expected by the application, and the actual content of the folder storing the images. this discrepancy occurs on a very small percentage of studies, and may result in the following:- a small number of images, typically a single image, in an individual study may be lost or unavailable; and/or- the study is not archived in long-term storage without manual correction of the discrepancy.If the issue occurs, it is possible that clinical decisions will be made using an incomplete set of images. this may result in inappropriate care leading to patient harm and/or a need to retake images.
  • Acción
    McKesson will provide a resolution to this issue through a software update which may require changing your software version. A Device Technology Australia representative will contact customers to organise the software upgrade. Thia action has been closed-out

Device

Horizon Medical Imaging products versions 4.5 up to and including 11.9 and McKesson Radiology 12....
  • Modelo / Serial
    Horizon Medical Imaging products versions 4.5 up to and including 11.9 and McKesson Radiology 12.0 (Radiology picture archiving and communication system)ARTG Number: 158895 (TBC)
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd