Events

Retiro De Equipo (Recall) de Philips Trauma Diagnost X-ray SystemsAll Trauma Diagnost systems delivered prior to 8th of July 2007 are affected.

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-2015-RN-00735-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-08-13
  • 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-00735-1
  • 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
    If two of the three fixation bolts of the trauma supporting block connecting the trauma arm with the cs telescope arm are cracked out of its thread, the trauma arm is no longer fastened securely. subsequently, the 3rd bolt may easily break during normal use and the trauma arm would fall down. there is a potential that the c-arm could fall down onto the table and impact on the patient or bystander. the following factors are required for this situation to occur:- unusual wear and tear (e.G. multiple collisions)- there is more than one broken fixation screw and the user is unaware- operator is in contact with, moves, or operates the trauma arm- a person is situated below the trauma arm.
  • Acción
    A Philips Service Engineer will contact affected customers as soon as the Field Action Kit is ready to be implemented. Philips is recommending the customers not to position the ceiling suspension with the Trauma arm directly above a patient until Philips Service Engineer repairs the affected systems. This action has been closed-out on 06/09/2016.

Device

Philips Trauma Diagnost X-ray SystemsAll Trauma Diagnost systems delivered prior to 8th of July 2...
  • Modelo / Serial
    Philips Trauma Diagnost X-ray SystemsAll Trauma Diagnost systems delivered prior to 8th of July 2007 are affected.ARTG Number: 100344
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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