Events

Alerte Ou Avis De Sécurité sur VitreaCore® software versions 6.0 to 6.5 inclusive, including all upgrades (except 6.3.1, 6.4.4 and 6.4.5)

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par Vital Images.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert / Field Safety Notice
  • ID de l'événement
    MDA/2014/002
  • Numéro de l'événement
    CON362320
  • Date
    2014-01-07
  • Date de publication de l'événement
    2014-01-07
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON362320?tabName=allTabs
  • Notes / Alertes
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Notes supplémentaires dans les données
  • Cause
    Risk of patient misdiagnosis or inappropriate treatment due to incorrect image orientation marking. this may occur when loading a study into the 3d viewer in vitreacore, taking a 16-bit secondary capture snapshot of the study and loading this snapshot in a dicom viewer. vital images has provided advice on how to confirm that snapshots are correctly marked.
  • Action
    Identify affected devices. Ensure members of staff are aware of the advice and guidance detailed in the manufacturer’s Field Safety Notice (FSN). Consider the need to review images taken prior to this notification due to the risk of misdiagnosis and/or inappropriate treatment  Place a copy of the addendum into the instructions for use. Complete and return the manufacturer’s ‘Effectiveness Check’ form. Radiologists Radiographers

Device

VitreaCore® software versions 6.0 to 6.5 inclusive, including all upgrades (except 6.3.1, 6.4.4 a...
  • Modèle / numéro de série
  • Description du dispositif
    Workstation software for computed tomography systems: VitreaCore® software versions 6.0 to 6.5 inclusive, including all upgrades (except 6.3.1, 6.4.4 and 6.4.5).
  • Manufacturer
    Vital Images

Manufacturer

Vital Images
  • Société-mère du fabricant (2017)
    Canon Inc
  • Source
    MHRA