Events

Retiro De Equipo (Recall) de Philips MX 16-slice CT systems featured with Lung Nodule Analysis

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-2016-RN-01603-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-12-09
  • 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-2016-RN-01603-1
  • 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 formula of doubling time is incorrectly defined in lung nodule analysis (lna). this may result in the wrong calculation result of doubling time, which may lead to misdiagnosis. lna is an optional tool that is only featured on mx 16-slice systems with software version 2.0.
  • Acción
    Philips will upgrade the system software and replace the software discs free of change. Before the software is upgraded, customers are advised not to refer to the parameter of “Doubling Time [day]” in Lung Nodule Analysis, instead refer to the parameter “Growth Rate [%]” for the growth of nodules.

Device

Philips MX 16-slice CT systems featured with Lung Nodule Analysis
  • Modelo / Serial
    Philips MX 16-slice CT systems featured with Lung Nodule AnalysisSerial numbers: 100006, 200019, 200065, 200001, 200021, 200067, 200002, 200022, 200071, 200009, 200023, 200079, 200011, 200026, 200083, 200014, 200029, 200084, 200016, 200035, 200090, 200017, 200059, 200092, 200018, 200062, 200078ARTG Number: 158775
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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