Events

Retiro De Equipo (Recall) de Aidacare FL250 Bed, Single and King Single

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Aidacare 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-00840-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2018-07-02
  • 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-00840-1
  • 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
    Aidacare has identified a labelling error pertaining to electrical classification on the manufacturer id sticker – it is shown as class ii device when the device is class i. this mislabelling creates the potential for testing and tagging to be incorrectly administered on fl250 beds.The class is labelled correctly on the control unit under the bed.
  • Acción
    Aidacare is advising that they will contact impacted customers to arrange for on-site correction.

Device

Aidacare FL250 Bed, Single and King Single
  • Modelo / Serial
    Aidacare FL250 Bed, Single and King SingleProduct Codes: BEB046100 (Single) and BEB046150 (King Single)Dates of Manufacture – 22 June 2017 to 17 May 2018ARTG Number: 287924(Aidacare Pty Ltd - Bed, disabled person, electrical)
  • Manufacturer
    Aidacare Pty Ltd

Manufacturer

Aidacare Pty Ltd