Events

Retiro De Equipo (Recall) de TDL6000MC Disposable Diathermy - Spatula tip with handle (Electrosurgical electrode)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Life Healthcare 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-2013-RN-01073-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-10-16
  • 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-01073-1
  • 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 recall is due to the two pieces of insulation on the handle not overlapping sufficiently, allowing the diathermy pen to spark through the insulation join when used with high voltage.This recall action was carried out prior to approval of the recall communication by the tga.
  • Acción
    Life Healthcare has removed the affected stock from the customers. The manufacturer has redesigned the insulation to a one piece construction to remove the failure mode.

Device

TDL6000MC Disposable Diathermy - Spatula tip with handle (Electrosurgical electrode)
  • Modelo / Serial
    TDL6000MC Disposable Diathermy - Spatula tip with handle (Electrosurgical electrode)Lot Number: 1219857ARTG Number: 198434
  • Manufacturer
    Life Healthcare Pty Ltd

Manufacturer

Life Healthcare Pty Ltd