Events

Retiro De Equipo (Recall) de Merge iConnect Enterprise Archive (iCEA) with software versions 8.30.7 through 9.4.3, with tier 2 storage enabled (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-00864-1
  • 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-00864-1
  • 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 icea which could result in unrecoverable loss of data when using tiered storage on icea. the issue can arise if a study has purged from tier 1 (i.E. via high water mark) and only resides in tier 2 and then the study is requested to be updated.In a tiered storage environment older data (less frequently accessed data) is staged to a second storage tier for long term storage. this staging process frees up space on the first storage tier for newer data. in rare circumstances, where the data that exists only on the second tier needs to be accessed, a software issue could lead to data being purged from both the first and second tier resulting in data loss. this issue may result in an archived study not being available for future viewing (i.E. as a prior study for comparison purposes, etc.). if prior studies are not available for viewing, this may lead to delay in treatment in determining the progression of the disease.
  • Acción
    Emergo is advising users to create a new object and remove the reference to the original version in order to prevent the issue from occurring. Emergo will be implementing a software update as a permanent correction. This action has been closed-out on 22/02/2017.

Device

Merge iConnect Enterprise Archive (iCEA) with software versions 8.30.7 through 9.4.3, with tier 2...
  • Modelo / Serial
    Merge iConnect Enterprise Archive (iCEA) with software versions 8.30.7 through 9.4.3, with tier 2 storage enabled (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