Events

Retiro De Equipo (Recall) de Synapse Cardiovascular (CV) Client application, version 4.0.8 (Picture archiving and communication 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 Fujifilm Australia Pty Ltd.

¿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-2014-RN-00482-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-05-07
  • 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-2014-RN-00482-1
  • 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
    The “switch user” feature is an option in windows 7 that allows another user to open a new session with his user account without requiring the previous user to log out of the existing session. it has been discovered that running the same synapse cv client application under more than one windows user account simultaneously may cause outbound hl7 reports with incorrect data to be sent to emr. there is the potential that patients’ medical records may be altered as a result of utilizing this windows 7 function through the unintentional modification of the outbound hl7 files. this issue does not occur if individual users logout of windows 7.
  • Acción
    Fujifilm does not support the use of the “Switch User” function in Windows 7 with Synapse CV. The function should be disabled on Windows 7 workstations that operate the Synapse CV application. There are several options to allow multiple users on a workstation and, if required, Fujifilm Customer Support will assist users with determining which option is best suited for each facility.

Device

Synapse Cardiovascular (CV) Client application, version 4.0.8 (Picture archiving and communicatio...
  • Modelo / Serial
    Synapse Cardiovascular (CV) Client application, version 4.0.8 (Picture archiving and communication system)ARTG number: 164422
  • Manufacturer
    Fujifilm Australia Pty Ltd

Manufacturer

Fujifilm Australia Pty Ltd