Events

Rappel de AutoSPECT Pro Reconstruction application on Intellispace Portal software versions 5.0, 6.0 and 7.0

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Philips Electronics Australia Ltd.

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
    RC-2016-RN-00385-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-04-01
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00385-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    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
  • Société-mère du fabricant (2017)
    Philips
  • Source
    DHTGA