Events

Retiro De Equipo (Recall) de Merge PACS with software versions V6.0.2.0 MR2 and earlier (a picture archiving and communications 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 Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

¿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-2016-RN-00862-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-06-30
  • 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-2016-RN-00862-1
  • 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
    This recall has been initiated due to an issue in which the patient name in the halo title bar may not update to match the name on displayed images due to the java running out of memory. this may result in a mismatch of the displayed patient name on the halo title bar and the displayed images. this may result in a delay in diagnosis or treatment or patient misdiagnosis. there have been no reports of injuries as a result of this issue.
  • Acción
    A released software fix available for this issue. A software update has been released which adds a warning message to the user interface for the user to close some viewers whenever the Java memory usage size exceeds 97%. In the interim, Emergo is advising users to ensure the correct patient name is displayed in the Halo title bar. This action has been closed-out on 22/02/2017.

Device

Merge PACS with software versions V6.0.2.0 MR2 and earlier (a picture archiving and communication...

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia