Events

Safety Alert Or Field Safety Notices for VitreaCore® software versions 6.0 to 6.5 inclusive, including all upgrades (except 6.3.1, 6.4.4 and 6.4.5)

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/2014/002
  • Event Number
    CON362320
  • Date
    2014-01-07
  • Event Date Posted
    2014-01-07
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON362320?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 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...
  • Model / Serial
  • Product Description
    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
  • Manufacturer Parent Company (2017)
    Canon Inc
  • Source
    MHRA