Events

Retiro De Equipo (Recall) de STERIS 5085 and 5085SRT Surgical Table

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Device Technologies 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-01185-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-11-07
  • 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-01185-1
  • 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, steris corporation, has learned through customer feedback and field service experience that the shroud cover for the hydraulic column may become misaligned and damaged as a result of extreme articulation or excessive pressure on the side or base of the table. in most instances, the shroud damage is minor and does not affect the vertical up/down movement of the hydraulic column. in cases of sever shroud damage, the shroud sections may become misaligned such that vertical movement of the hydraulic column is impeded. no patient injury or adverse health outcomes have been reported due to this issue.
  • Acción
    Device Technologies Australia (DTA) representative will contact the customer to arrange an upgrade to correct the problem. DTA is also advising customers that the 5085/5085SRT Surgical Tables can continue to be operated in the interim. This action has been closed-out on 11/08/2016.

Device

STERIS 5085 and 5085SRT Surgical Table
  • Modelo / Serial
    STERIS 5085 and 5085SRT Surgical Table Product codes: ST-01-410-1, ST-01-460-7, ST-480-7 and ST-01-480-06 Serial Number Range: 0403809001-0425514019ARTG number: 149156
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd