Events

Retiro De Equipo (Recall) de i-Optics’ Cassini, Corneal Topographer, with a recent software upgrade to version 2.0.0

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por IQ Medical.

¿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-01265-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-12-04
  • 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-01265-1
  • 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
    After upgrading the cassini software to version 2.0.0, the cassini patient database may have beencompromised, resulting in patient examination data being linked to the wrong patient.
  • Acción
    Technical support representative will contact affected customers to inspect and, if necessary, to correct the issue. During the restoration process, the Cassini device will be locked and cannot be used. This is estimated to take 1 to 3 hours. Until the database integrity has been ensured, users are advised not to use patient examination data unless verified to be correctly associated with the patient. A software patch is under development (version 2.0.1, expected mid-December) including making a back-up before updating and a database check before and after an update. This action was undertaken prior to consultation with the Therapeutic Goods Administration. This action has been closed out on 29/01/2016.

Device

i-Optics’ Cassini, Corneal Topographer, with a recent software upgrade to version 2.0.0
  • Modelo / Serial
    i-Optics’ Cassini, Corneal Topographer, with a recent software upgrade to version 2.0.0ARTG Number: 219343 (TBC)
  • Manufacturer
    IQ Medical

Manufacturer

IQ Medical