Events

Retiro De Equipo (Recall) de Mizuho OSI 5855 Orthopedic Table Top Manufactured January 1996 through December 2007

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-00069-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-01-22
  • 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-00069-1
  • 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
    This action has been initiated to eliminate the risk of de-lamination of the epoxy bond between the 5855-01 orthopedic table spar's aluminium insert and the carbon fibre spar itself. if the epoxy bond fails the aluminium plug may migrate out of the carbon fibre tube.
  • Acción
    Customers are being advised to inspect the table top for any evidence of a shift of the aluminium plug from the carbon spar and immediately contact LifeHealthcare if apparent. Hospitals will be contacted to schedule an appointment to replace the table spar.

Device

Mizuho OSI 5855 Orthopedic Table Top Manufactured January 1996 through December 2007
  • Modelo / Serial
    Mizuho OSI 5855 Orthopedic Table TopManufactured January 1996 through December 2007ARTG 183118
  • Manufacturer
    Life Healthcare Pty Ltd

Manufacturer

Life Healthcare Pty Ltd