Events

Retiro De Equipo (Recall) de AutoSPECT Pro Reconstruction application on Intellispace Portal software versions 5.0, 6.0 and 7.0

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-00385-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-04-01
  • 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-00385-1
  • 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
    Autospect pro is an application residing on intellispace portal workstation used to process, analyse, and display medical images/data obtained from other devices, including gamma cameras, which may be used in diagnosis. the application was designed to reconstruct cardiac spect data obtained with detectors positioned at 90° or 180° relative to one another. however, certain gamma cameras (marconi axis and irix), permit acquisitions at other relative detector angles. data acquired at these other angles will not be correctly reconstructed by autospect pro.Although unlikely, there is potential that reliance on these results could lead to 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 such as myocardial infarction. 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 these 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.

Device

AutoSPECT Pro Reconstruction application on Intellispace Portal software versions 5.0, 6.0 and 7.0
  • Modelo / Serial
    AutoSPECT Pro Reconstruction application on Intellispace Portal software versions 5.0, 6.0 and 7.0ARTG Number: 119929
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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