Events

Retiro De Equipo (Recall) de Vatech X-Ray System, models: Pax-500, Pax-Uni3D, pax-Reve3D and Duo3D and Picasso 3D (Dental x-ray system)Manufactured between 15 May 2009 and 15 July 2009.

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Vatech Medical 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-2012-RN-01219-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-12-04
  • 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-2012-RN-01219-1
  • 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 manufacturer has identified these products as possibly having a faulty coupling spacer. the coupling spacer used during this period was made out of plastic and in some instances the plastic spacer can break. when the coupling spacer is damaged, the column shaft will make a noisy sound when the operator continues to adjust the up/down switch.This recall action was not notified to the tga before it was initiated by vatech medical.
  • Acción
    The sponsor is providing users with work around instructions and will be replacing the spacers on all affected devices.

Device

Vatech X-Ray System, models: Pax-500, Pax-Uni3D, pax-Reve3D and Duo3D and Picasso 3D (Dental x-ra...
  • Modelo / Serial
    Vatech X-Ray System, models: Pax-500, Pax-Uni3D, pax-Reve3D and Duo3D and Picasso 3D (Dental x-ray system)Manufactured between 15 May 2009 and 15 July 2009. ARTG Number: 199091
  • Manufacturer
    Vatech Medical Pty Ltd

Manufacturer

Vatech Medical Pty Ltd