Events

Retiro De Equipo (Recall) de Philips BrightView / BrightView X / BrightView XCT and BrightView X upgrade to XCT (Nuclear medicine gamma camera and SPECT/CT systems)

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-00260-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-02-24
  • 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-00260-1
  • 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
    Several issues have been identified with philips brightview, brightview x and brightview xct leading to a need to re-scan the patient:-brightview xct systems only:- motion controller emits the warning message; and- door interlock switch with x ray perform.For both brightview x and xct systems:- detector contacts head holder when performing patient unloadfor brightview, brightview x, and brightview xct systems:- jetstream freezes during gated planar scan.
  • Acción
    Philips is notifying the affected users of these issues via this Customer Information Letter. Customers will be contacted by a Philips Field Service Engineer for implementation of the necessary software corrections free of charge.

Device

Philips BrightView / BrightView X / BrightView XCT and BrightView X upgrade to XCT (Nuclear medic...
  • Modelo / Serial
    Philips BrightView / BrightView X / BrightView XCT and BrightView X upgrade to XCT (Nuclear medicine gamma camera and SPECT/CT systems)Model Number and Device Name: 882480 - BrightViewSoftware versions: 1.2.1, 1.2.2, 1.2.3, 1.2.4 and 1.2.5Model Number and Device Name: 882478 - BrightView X882482 - BrightView XCT882454 - BrightView X upgrade to XCTSoftware versions: 2.5.1, 2.5.2, 2.5.3, 2.5.4 and 2.5.5ARTG Numbers: 117642, 117440
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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