Events

Safety Alert Or Field Safety Notices for Vitrea fX, Vitrea and Vitrea Enterprise Suite

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Vital Images.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Event ID
    MDA/2012/081
  • Event Number
    CON208699
  • Date
    2012-11-29
  • Event Date Posted
    2012-11-29
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON208699?tabName=allTabs
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    Risk of misdiagnosis and treatment of vessels due to incorrect calcium scores. there is the potential for errors in calcium score values in restored snapshots of studies generated through use of these devices. if these calcium scores are relied upon, less–healthy vessels may be incorrectly considered as healthy, which may lead to incorrect or sub optimal treatment paths being followed.
  • Action
    Identify affected systems. Contact the manufacturer to arrange installation of the software update. Follow the workarounds described in the manufacturer’s Field Safety Notice regarding selection of manual method and interpolate functions. Assess the need to review previous patients' treatment plans.

Device

Vitrea fX, Vitrea and Vitrea Enterprise Suite
  • Model / Serial
  • Product Description
    Workstation software for computed tomography systems: Vitrea fX, Vitrea and Vitrea Enterprise Suite. Various software versions are affected. Affected software versions are: Vitrea fX – versions     3.1, 6.0, 6.1, 6.2 Vitrea – versions 5.2, 6.0, 6.1, 6.2 Vitrea Enterprise Suite – versions 1.3, 6.0, 6.1, 6.2
  • Manufacturer
    Vital Images

Manufacturer

Vital Images
  • Manufacturer Parent Company (2017)
    Canon Inc
  • Source
    MHRA