Events

Retiro De Equipo (Recall) de Prius Hospital Bed

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Prius Healthcare Solutions 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-2015-RN-00381-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2015-05-13
  • 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-2015-RN-00381-1
  • 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
    Dickson & dickson healthcare have received a corrective action notice from the manufacturer of this bed to replace incorrect product labelling. prius beds manufactured in may 2015 and july 2015 have the incorrect manufacturer details stated on the label. after consultation with tga, dickson & dickson healthcare ltd is performing a recall for product correction to replace affected labels with the correct information.The labels are to be replaced on all beds in order to comply with the essential principles.
  • Acción
    Dickson & Dickson Healthcare is arranging replacement of the labels on all affected beds which will display the correct manufacturers details. This action has been closed-out on 03/03/2016.

Device

Prius Hospital Bed

Manufacturer

Prius Healthcare Solutions Pty Ltd