Events

Retiro De Equipo (Recall) de Mobile Shower and Toilet Commode Aquatec Ocean VIP

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Invacare 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-00518-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-05-20
  • 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-2014-RN-00518-1
  • 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 has advised that during regular market observation they noticed that some of the snap-on fixtures do not withstand the required pull out force. this was caused due to an inconsistency of the injection moulding, and did not meet the design specification for the snap-on fixtures. the male portion of the clip has a 90-degree angle overhang; and this was not completely filled as per specification. the attachment mechanism has the potential to unintentionally open when the product is used in the recline position.
  • Acción
    Invacare is requesting the device providers to locate all affected Mobile Shower and Toilet Commode Aquatec Ocean VIP and replace the faulty clips. Further information on this recall action can be found on the TGA website at http://www.tga.gov.au/safety/alerts-device-aquatec-ocean-vip-mobile-shower-toilet-commode-140522.htm . This action has been closed-out on 04/04/2017

Device

Mobile Shower and Toilet Commode Aquatec Ocean VIP
  • Modelo / Serial
    Mobile Shower and Toilet Commode Aquatec Ocean VIPMultiple serial numbers affectedARTG Number: 153914
  • Manufacturer
    Invacare Australia Pty Ltd

Manufacturer

Invacare Australia Pty Ltd