Events

Retiro De Equipo (Recall) de ADAC ARGUS Gamma Camera Systems (Nuclear medicine system)

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-2013-RN-01149-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-11-08
  • 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-2013-RN-01149-1
  • 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
    A recent investigation has determined that visual inspections of the fork joints behind the detector that is conducted during six month preventive maintenance (pm) may not detect small cracks or deficiencies in the fork weldment. a failure in the fork weldment has the potential to cause the detector assembly to detach, resulting in serious injury or death to a patient, operator or service personnel member if he or she is in the direct path of the detector assembly and the weldment fails.
  • Acción
    Philips Electronics Australia is informing the customers to immediately cease the use of the affected systems. The manufacturer is currently undertaking further analysis regarding the issue and there will be further communication to the customers relating to the corrective action, once the investigation is finalised. This action has been closed-out on 29/01/2016

Device

ADAC ARGUS Gamma Camera Systems (Nuclear medicine system)

Manufacturer

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