Events

Alerte Ou Avis De Sécurité sur Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX, all versions prior to version 6.3.3

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/2013/023
  • Numéro de l'événement
    CON261810
  • Date
    2013-04-12
  • Date de publication de l'événement
    2013-04-12
  • 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/CON261810?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 measurement error when images are rotated at the time of reconstruction. there is the potential for volume errors of -50% and length errors of -29%, depending on the degree to which the images are rotated. this problem occurs when images are rotated at the time of reconstruction by the scanner in non-90 degree increments of the transverse/axial plane (rotation around the z-axis), while not being simultaneously rotated around the x-axis and y-axis. for these scans, the images will shrink. the severity of the shrinking is dependent on the degree (or extent) of image rotation. the maximum error is seen with a 45 degree rotation which results in a length measurement being under-reported by 29% and a volume measurement being under-reported by 50%.
  • Action
    Identify affected devices. Ensure members of staff are aware of the advice detailed in the manufacturer’s Field Safety Notice (FSN) and its update. Ensure that all measurements associated with the error described in the FSN are verified against results from other technologies. Notify Vital Images that you have received the FSN to arrange for installation of a software patch. Assess the need to review previous patients' treatment plans. Radiologists Radiographers Oncologists Medical physicists

Device

Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX, all ver...
  • Modèle / numéro de série
  • Description du dispositif
    Workstation software for computed tomography systems: Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX, all versions prior to version 6.3.3.
  • Manufacturer
    Vital Images

Manufacturer

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