Events

Retiro De Equipo (Recall) de Horizon Medical Imaging Products Versions 4.6.1 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-00689-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-06-30
  • 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-00689-1
  • 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
    Mckesson has identified a rare software issue when two or more processes attempt to modify the same image folder within fractions of a second, the write lock mechanism may fail to prevent concurrent modification of the same data. this may result in loss of data within the image folder. as both simultaneous write access and lock mechanism failures are rare, the likelihood of experiencing this problem is very low.
  • Acción
    The manufacturer, McKeeson Medical Imaging, will provide a software update to resolve this issue. Until the issue is resolved end users are advised to ensure that all expected images are present in a study prior to completing the Technologist workflow. Thia action has been closed-out on 28/01/2016

Device

Horizon Medical Imaging Products Versions 4.6.1 up to and including 11.9 and McKesson Radiology 1...
  • Modelo / Serial
    Horizon Medical Imaging Products Versions 4.6.1 up to and including 11.9 and McKesson Radiology 12.0 (Radiology picture archiving and communication system)ARTG Number: 158895
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd