Events

Retiro De Equipo (Recall) de Heron Toilet and Bath Chair

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por R82 AU 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-2017-RN-00858-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-07-11
  • 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-2017-RN-00858-1
  • 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
    R82 australia has been informed about breakage of the aluminium gas spring head for the tilting mechanism on the heron. this particular part was changed to a stainless steel version as of january 2016 and replacement kits are to be provided for replacement on units that still have the aluminium version to eliminate the risk of other breakages.
  • Acción
    R82 is undertaking a voluntary measure of sending out stainless steel kits to replace the aluminium units to eliminate the risk of breakages and the potential for related injury. Affected customers are asked to follow the instructions in the customer letter to obtain the new kits.

Device

Heron Toilet and Bath Chair
  • Modelo / Serial
    Heron Toilet and Bath Chair Article Numbers: 880505-01 and 880505-11Manufactured between 23rd October 2013 to the 16th December 2015ARTG Number: 229744
  • Manufacturer
    R82 AU Pty Ltd

Manufacturer

R82 AU Pty Ltd