Events

Rappel de Philips AutoSPECT Pro Reconstruction application on Extended Brilliance Workspace

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Philips Radiation Oncology Systems.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    20038
  • Date de mise en oeuvre de l'événement
    2016-04-18
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Recalling Organisation: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
  • Cause
    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.
  • Action
    Software to be upgraded

Device

Philips AutoSPECT Pro Reconstruction application on Extended Brilliance Workspace

Manufacturer

Philips Radiation Oncology Systems
  • Société-mère du fabricant (2017)
    Philips
  • Source
    NZMMDSA