Events

Retiro De Equipo (Recall) de Philips AutoSPECT Pro Reconstruction application on Extended Brilliance Workspace

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Philips Radiation Oncology Systems.

¿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
    20038
  • Fecha de inicio del evento
    2016-04-18
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
  • Causa
    Autospect pro is a spect reconstruction application residing on the extended brilliance workspace nm workstation. it was found that the software may display incorrect results if the data processed is derived from spect acquisitions using detectors positioned at angles other than 90° or 180° relative to on another. 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 for a subsequent cardiovascular event. many gamma cameras only allow acquisitions at relative 90° or 180°, so this issue cannot occur when reconstructing data obtained with those systems. philips has not received any report of any patient harm associated with this issue.
  • Acción
    Software to be upgraded

Device

Philips AutoSPECT Pro Reconstruction application on Extended Brilliance Workspace

Manufacturer

Philips Radiation Oncology Systems
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    NZMMDSA