Events

Retiro De Equipo (Recall) de AutoSPECT Pro Reconstruction application on Extended Brilliance Workplace NM software version 2.0(used to process, analyse, and display medical images/data obtained from other diagnostic devices, including gamma cameras)

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-00384-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-04-06
  • 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-00384-1
  • 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 autospect pro application was only designed to reconstruct cardiac spect data obtained with detectors positioned at 90° or 180° relative to one another. however, certain gamma cameras, e.G., the marconi axis and irix cameras, permit acquisitions at other relative detector angles. data acquired at these other angles will not be correctly reconstructed by autospect pro, and the results will likely be erroneous.Incorrect computational results may lead, under certain circumstances to misdiagnosis, e.G., an incorrect assessment of a patient’s myocardial perfusion, in which case, the patient may not receive further indicated diagnostic tests or therapy, putting the patient at risk of a subsequent cardiovascular event.Philips has not received any report of any patient harm associated with this issue.
  • Acción
    Philips is advising users to follow instructions in the customer letter to determine whether the system is affected. If it is affected, users are asked NOT to use the AutoSPECT Pro application on the affected data sets until Philips modifies its software to prevent it from reconstructing data acquired using these modes. Instead, use the reconstruction applications on the camera’s native processing computers (e.g. Odyssey). Philips is recommending a review of previously processed data based on the clinical context. This action has been closed-out on 27/01/2017.

Device

AutoSPECT Pro Reconstruction application on Extended Brilliance Workplace NM software version 2.0...
  • Modelo / Serial
    AutoSPECT Pro Reconstruction application on Extended Brilliance Workplace NM software version 2.0(used to process, analyse, and display medical images/data obtained from other diagnostic devices, including gamma cameras)ARTG Number: 117441
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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