Events

Safety Alert Or Field Safety Notices for Vitrea CT Brain Perfusion 2D application

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/2013/039
  • Event Number
    CON286870
  • Event Date Posted
    2013-06-13
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON286870?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 patient misdiagnosis, inappropriate treatment or treatment delay due to incompatibility of software with certain protocols or ct units. analysis of data in vitrea ct brain perfusion 2d may lead to inaccurate perfusion maps if the data is acquired by an unsupported ct scanner. vital images has provided advice on the systems that are and are not supported.
  • 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 prior examinations. Place a copy of the FSN into the instructions for use. Complete and return the manufacturer’s ‘Effectiveness Check’ form. Radiologists Radiographers Medical physicists

Device

Vitrea CT Brain Perfusion 2D application
  • Model / Serial
  • Product Description
    Workstation software for computed tomography systems: Vitrea CT Brain Perfusion 2D application. Versions 6.0 and above for Vitrea Enterprise Suite, Vitrea, VitreaAdvanced and Vitrea fX are affected.
  • Manufacturer
    Vital Images

Manufacturer

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