Events

Safety Alert Or Field Safety Notices for Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX, all versions prior to version 6.3.3

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/2013/023
  • Event Number
    CON261810
  • Date
    2013-04-12
  • Event Date Posted
    2013-04-12
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON261810?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 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...
  • Model / Serial
  • Product Description
    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
  • Manufacturer Parent Company (2017)
    Canon Inc
  • Source
    MHRA