Events

Retiro De Equipo (Recall) de NX workstation with NX 3.0.8950 image processing software

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-2017-RN-00131-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-01-27
  • 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-2017-RN-00131-1
  • 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
    Due to a memory issue, users are shown a warning message about unexpected error and possible incorrect data integrity. a reboot of the workstation computer after having received the warning message prevents the issue from occurring. at this stage, there has been one instance whereby the warning instructions were not followed and resulted in the image of one patient being archived in another patient’s record.
  • Acción
    In order to prevent this issue, Agfa HealthCare is advising users to conduct a daily reboot of their workstation by completely turning off the computer and then restarting it. Users are further advised to follow all warning instructions as indicated on their NX workstation and reboot the workstation’s computer if a warning message appears. A new version of the NX software (3.0.9000) will be released shortly and users will receive this upgrade to their installations accordingly.

Device

NX workstation with NX 3.0.8950 image processing software
  • Modelo / Serial
    NX workstation with NX 3.0.8950 image processing softwareARTG Numbers: 119463, 173861, 178856
  • Manufacturer
    AGFA HealthCare Australia

Manufacturer

AGFA HealthCare Australia