Events

Retiro De Equipo (Recall) de Allura Xper FD20 R8.2

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Philips Electronics Australia 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-2017-RN-00898-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2017-07-20
  • 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-2017-RN-00898-1
  • 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
    Philips has identified that the protecting earth (pe) cable between a motion controller and the pe star point was not installed on the affected product.The lack of this aforementioned protective earth cable makes the system not compliant with the iec60601-1 standard for protective earthing, however there is no risk for patients / operators / users since the frame is connected to protective earth (pe) and the unit involved is shielded with a cover.The relevant parts are in the technical (equipment) room and therefore not accessible for patients. to date, philips is not aware of any injuries that may have occurred as result of this situation.
  • Acción
    Philips is requesting customers: 1. Read the supplied notice; 2. Place the notice with the documentation of the system until this correction has been implemented; and 3. Complete the supplied response form and return it to Philips via fax/email within 3 business days of receiving the customer letter.

Device

Allura Xper FD20 R8.2

Manufacturer

Philips Electronics Australia Ltd
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DHTGA