Events

Retiro De Equipo (Recall) de Trumpf Table Top Spinal System (T3SYSTEM) Manufacturing Dates: March 2009 to November 2016

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Trumpf Med Aust 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-2018-RN-00316-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-04-20
  • 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-2018-RN-00316-1
  • 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
    Allen medical has become aware that the rail section clamps used to attach the leg support of the t3 trumpf table may fail during use, which could result in critical harm to the patient. the t3 trumpf table top rail section clamps, f-t3railsc, are designed and labelled for use with armboards only but were shipped to be used with the leg support. the instructions for use (d-720595-a3) incorrectly guides the user to connect the top rail section clamp to the leg support.Three complaints without any allegation of injury have been reported since introduction in september 2009.
  • Acción
    Trumpf are advising users to ensure that the T3 Trumpf Table Top Rail Section Clamps are used with armboards only. Users should inspect beds and remove any clamps currently in use with the Leg support. Allen Medical will be providing users with new Rail Section Clamps along with revised Instructions for Use. These are expected to be available by May 2018.

Device

Trumpf Table Top Spinal System (T3SYSTEM) Manufacturing Dates: March 2009 to November 2016
  • Modelo / Serial
    Trumpf Table Top Spinal System (T3SYSTEM)Manufacturing Dates: March 2009 to November 2016ARTG Number: 252619(Trumpf Med Aust - Table, operation)
  • Manufacturer
    Trumpf Med Aust Pty Ltd

Manufacturer

Trumpf Med Aust Pty Ltd