Events

Retiro De Equipo (Recall) de Merge PACS with software versions 6.5.5, 6.5.6, 6.5.7, 6.5.8, 6.5.9, 6.6, 6.6.1, 6.6.1.1, 6.6.2 (picture archiving and communication system) Distributed between June 2008 and June 2015

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-00863-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-06-29
  • 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-00863-1
  • 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 merge pacs inability to display presentation states on prior comparison studies generated on 3rd party systems or that have been migrated from office pacs. these presentation states are known as foreign presentation states. pacs 6.5.5 introduced the feature to be able to display foreign presentation states. however this feature was only available on the primary study in any given viewer instance. it did not apply to prior comparison studies that were opened in the same viewer. users might assume that if the annotations are available in the primary study, they would also be shown if available on the prior comparison studies.Use of this product may cause a user to believe that there was nothing significant seen in the prior image which may result in improper treatment. there have been no injuries reported as a result of this issue.
  • Acción
    Emergo are advising users to open prior comparison studies in the secondary viewer to check if there were annotations and read the report, or visit notes pertaining to that study to see if there are any noted findings that are otherwise not apparent. Emergo will be implementing a software upgrade as a permanent correction. This action has been closed-out on 23/05/2017.

Device

Merge PACS with software versions 6.5.5, 6.5.6, 6.5.7, 6.5.8, 6.5.9, 6.6, 6.6.1, 6.6.1.1, 6.6.2 (...
  • Modelo / Serial
    Merge PACS with software versions 6.5.5, 6.5.6, 6.5.7, 6.5.8, 6.5.9, 6.6, 6.6.1, 6.6.1.1, 6.6.2 (picture archiving and communication system)Distributed between June 2008 and June 2015ARTG Number: 191068
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia