Events

Retiro De Equipo (Recall) de Zippie Zone Wheelchair

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Sunrise Medical 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-00160-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-06-21
  • 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-00160-1
  • 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 zippie zone instructions for use (ifu) have been updated to provide clarification on the intended use and the correct prescription of the wheelchair prior to purchase.
  • Acción
    The IFU updates cover the correct usage of the chair and also improved guidance in the correct product selection and client suitability information. Customers with this particular chair model may download the updated instructions at: http://www.sunrisedice.com/asset-bank/assetfile/25518.pdf If users have any concerns regarding the correct usage/application or prescription regarding the chair they have been supplied, it is advised to discuss these concerns with the therapist or supplier in the first instance. Sunrise Medical is also providing a new "Paediatric Prescription Guide" to clients, therapists and clinicians as a reference whilst prescribing and/or assessing clients.

Device

Zippie Zone Wheelchair
  • Modelo / Serial
    Zippie Zone Wheelchair Model Number: EIRZ1 ARTG Number: 100167(SUNRISE MEDICAL PTY LIMITED - Wheelchair, )
  • Manufacturer
    Sunrise Medical Pty Ltd

Manufacturer

Sunrise Medical Pty Ltd