Events

Retiro De Equipo (Recall) de Merge iConnect Enterprise Archive (iCEA) with software versions: 5.30.0 and greater up to and including 9.4.3(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-00873-1
  • 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-00873-1
  • 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 because the impacted versions of icea allow images to be stored to the icea without pixel data. - image was retrieved by radsuite from icea, a qc action was performed, & sent back to icea. - image was sent to icea with pixel data but the pixel data was not stored with the image to icea. the investigation found that there is a networking scenario where the network dropped the connection after sending the header information but before the pixel data arrived. icea stored the image without the pixel data.- image was sent to icea without pixel data & the image was stored to icea. the pixel data may have been lost by the device that sent the data to icea.A side effect of images without pixel data is performance degradation caused by the system continuously attempting to route the images to the peer system that fail to store. there could be delay in treatment in determining the progression of disease.
  • Acción
    Emergo is advising users that there is no work around for the issue, however the error is obvious to users using PACS viewer, as it is indicated that there is a missing image (slice) from the study. Users not using PACS viewer may not be notified of the error. Emergo will be implementing a software upgrade as a permanent correction. This action has been closed-out on 22/02/2017.

Device

Merge iConnect Enterprise Archive (iCEA) with software versions: 5.30.0 and greater up to and inc...
  • Modelo / Serial
    Merge iConnect Enterprise Archive (iCEA) with software versions: 5.30.0 and greater up to and including 9.4.3(a picture archiving and communications system)ARTG Number: 206683
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia