Events

Retiro De Equipo (Recall) de Penumbra System Aspiration Pump - Pump Max, PMX220Multiple Lot Numbers

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Penumbra Neuro 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-2018-RN-00228-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2018-03-21
  • 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-00228-1
  • 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 australian sponsor address was inadvertently omitted from the pump max labelling.To date, no user complaints have been received regarding this issue.
  • Acción
    Penumbra is providing users with a label containing the Australian Sponsor details to affix to devices. Users should refer to the images provided on the Customer Letter for correct location as to where labels should be placed.

Device

Penumbra System Aspiration Pump - Pump Max, PMX220Multiple Lot Numbers
  • Modelo / Serial
    Penumbra System Aspiration Pump - Pump Max, PMX220Multiple Lot NumbersARTG Number: 213819(Penumbra Neuro Australia - Suction unit, electric powered)
  • Manufacturer
    Penumbra Neuro Australia Pty Ltd

Manufacturer

Penumbra Neuro Australia Pty Ltd