Events

Retiro De Equipo (Recall) de PHILIPS MX 16-slice CT System, software: v1.1.3.1167; v1.1.4.21425; v1.1.4.21424; v1.1.4.21422

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-2014-RN-01105-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-10-10
  • 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-2014-RN-01105-1
  • 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 orientation of images is displayed incorrectly. when operator chooses “gantry on the right side” from operation console, and the patient position is hfdl, hfdr, ffdl or ffdr, the patient position picture and text is not consistent. "l" and "r" of scan images are reversed and this is not consistent with the patient actual position. this issue may result in potential misdiagnosis or incorrect anatomy classification leading to unnecessary treatment/procedure.
  • Acción
    Philips is providing temporary work around instructions in the customer letter until updated software in a Service Pack is installed in the affected systems. The Service Pack will also correct the following other issues: - When a surview which is longer than 557mm is stopped by using “Abort” function during the scan process, the position of scan box in surview image is not correct. - For dental applications, when a patient scan is taken with Gantry tilted, and the tilt angle falls in the range from 1 to -1 degree (not including 0 degree position), the data post-processing may not operate normally and the images may not be displayed. - If the user stops a surview using the “Abort” function during the second part of the scan, the positions of the scan box are not consistent. This action has been closed-out on 09/08/2016.

Device

PHILIPS MX 16-slice CT System, software: v1.1.3.1167; v1.1.4.21425; v1.1.4.21424; v1.1.4.21422
  • Modelo / Serial
    PHILIPS MX 16-slice CT System, software: v1.1.3.1167; v1.1.4.21425; v1.1.4.21424; v1.1.4.21422ARTG number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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