Events

Retiro De Equipo (Recall) de IMPAX 5.2 DB Server, version 5.2 (Picture archiving and communication system, PACS)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por AGFA HealthCare 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-2013-RN-00317-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-04-18
  • 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-2013-RN-00317-1
  • 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
    System downtime and/or slow performance may result if software in use is not at supported levels. to be specific, it has been identified that oracle version 10.1.0.4.0 or older in use with impax 5.2 db server can cause oracle blocking sessions due to defect 360595 with fix available in oracle 10.2.0.2 and subsequent versions.
  • Acción
    Agfa HealthCare is advising that the ‘End of Service Life’ for IMPAX 5.2 was December 31, 2010. In order for Agfa HealthCare to continue to provide support, it is critical that sites upgrade to the latest version of IMPAX. In the interim, Agfa HealthCare strongly recommends installing the latest Oracle critical patch upgrades. Please see Oracle’s website for more details: http://www.oracle.com/technetwork/database/windows/downloads/index-101290.html .

Device

IMPAX 5.2 DB Server, version 5.2 (Picture archiving and communication system, PACS)

Manufacturer

AGFA HealthCare Australia