Events

Retiro De Equipo (Recall) de Merge OrthoCase with software versions 3.7.3 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-00869-1
  • 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-00869-1
  • 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
    When using the perpendicular line tool, there is an option to 'snap' the lines together, which prevents the perpendicular lines from extending past the straight/base line. when a perpendicular line measurement is made and saved in a plan, the line measurement value changes when the plan is reloaded. this is due to when the “snap to line” feature is enabled, it doesn’t apply automatically when the perpendicular line is drawn. it only gets applied when the saved plan is reloaded, so to the user, the measurements look different from what was saved. however, in each case (before/after “snap to line” is applied), the line measurement is accurate.If the line end point is within 20 pixels of the base line, it will adjust its location to snap perfectly to the base line. this may adjust the length and corresponding measurement of the perpendicular line when the plan is reopened.This may cause delay in diagnosis or treatment of patient, however the actual measurement of the line is accurate.
  • Acción
    Emergo is providing users with work around instructions to follow as an interim measure. A software upgrade will be implemented as a permanent correction. This action has been clsoed-out on 27/02/2017.

Device

Merge OrthoCase with software versions 3.7.3 and earlier (a picture archiving and communications ...

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia