Medical safety alert

VitreaCore® Workstation software for computed tomography systems - risk of patient misdiagnosis or inappropriate treatment

(Vital Images) Incorrect image orientation marking when loading a study into the 3D viewer. (MDA/2014/002)

CAS deadlines

Action underway: 21 January 2014, action complete: 4 February 2014
Note: These deadlines are for actions to be completed.

Device

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).

Manufactured by Vital Images.

Problem

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 (672Kb) (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 Field Safety Notice (672Kb) into the instructions for use.
  • Complete and return the manufacturer’s ‘Effectiveness Check’ form.

Action by

  • Radiologists
  • Radiographers

Distribution

This MDA has been sent to:  

  • Care Quality Commission (CQC) (headquarters) for information
  • Clinical commissioning groups (CCGs)
  • HSC trusts in Northern Ireland (chief executives)
  • Local authorities in Scotland (equipment co-ordinators)
  • NHS boards and trusts in Wales (chief executives)
  • NHS boards in Scotland (equipment co-ordinators)
  • NHS England area teams for information
  • NHS trusts in England (chief executives)

Onward distribution

Please bring this notice to the attention of relevant employees in your establishment. Below is a suggested list of recipients.

Trusts
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:

  • MRI units, directors of
  • Radiographer superintendents
  • Radiographers
  • Radiologists
  • Radiology departments
  • Radiology directors

Independent distribution

Establishments registered with the Care Quality Commission (CQC) (England only)
This alert should be read by:

  • Hospitals in the independent sector

Please note: CQC and OFSTED do not distribute these alerts. Independent healthcare providers and social care providers can sign up to receive MDAs directly from the Department of Health’s Central Alerting System (CAS) by sending an email to: safetyalerts@dh.gsi.gov.uk and requesting this facility.

Manufacturer contact

Manufacturer

Vincent Swenson
Sr. Director of Quality Systems and Regulatory Affairs
Vital Images, Inc.
5850 Opus Parkway Suite 300
Minnetonka
MN 55343-4414
USA
Tel: 01 952 487 9548
Fax: 01 952 540 3717

Email: vswenson@vitalimages.com

UK Distributor 

Stuart Ferguson - HII Business Unit Manager
Vital Images Europe BV
Bonnington Bond 2 Anderson Place
Edinburgh
EH6 5NP
United Kingdom
Tel: 0131 472 5723

Email: sferguson@vitalimages.com

Customer Support

Vital Images Customer Support Europe
Tel: 031 70 413 5801

Email: eusupport@vitalimages.com

Feedback

If you have any comments or feedback on this Medical Device Alert please email us at: dts@mhra.gsi.gov.uk.

England

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2014/002 or 2013/010/025/081/011.

Technical aspects

David Grainger or Paul Sandhu
Medicines & Healthcare Products Regulatory Agency
Floor 4, 151 Buckingham Palace Road
London 
SW1W 9SZ
Tel: 020 3080 7199 / 7266
Fax: 020 8754 3965

Email: david.grainger@mhra.gsi.gov.uk or paul.sandhu@mhra.gsi.gov.uk

Clinical aspects

Mark Grumbridge
Medicines & Healthcare Products Regulatory Agency
Floor 4, 151 Buckingham Palace Road
London 
SW1W 9SZ
Tel: 020 3080 7128
Fax: 020 8754 3965

Email: mark.grumbridge@mhra.gsi.gov.uk

How to report adverse incidents

Please report via our website: Reporting adverse incidents involving medical devices
Further information about CAS can be found on the CAS website 

Northern Ireland

Alerts in Northern Ireland will continue to be distributed via the NI SABS system.

Enquiries and adverse incident reports in Northern Ireland should be addressed to:

Northern Ireland Adverse Incident Centre
Health Estates Investment Group
Room 17
Annex 6
Castle Buildings, Stormont Estate
Dundonald BT4 3SQ
Tel: 02890 523 704
Fax: 02890 523 900

Email: NIAIC@dhsspsni.gov.uk

How to report adverse incidents in Northern Ireland

Please report directly to NIAIC, further information can be found on the NIAIC website 
Further information about SABS can be found on the SABS website 

Scotland

All requests regarding return, replacement or modification of the devices mentioned in this alert should be directed to the relevant supplier or manufacturer.

Other enquiries and adverse incident reports in Scotland should be addressed to:

Incident Reporting and Investigation Centre
NHS National Services Scotland
Gyle Square
1 South Gyle Crescent
Edinburgh EH12 9EB
Tel: 0131 275 7575  
Fax: 0131 314 0722

Email: nss.iric@nhs.net

Incident Reporting and Investigation Centre

Wales

Enquiries in Wales should be addressed to:

Improving Patient Safety Team
Medical Directorate
Welsh Government
Cathays Park
Cardiff CF10 3NQ
Tel: 029 2082 5801 

 
Email: Haz-Aic@wales.gsi.gov.uk

Download documents

Medical Device Alert: VitreaCore® Workstation software for computed tomography systems, manufactured by Vital Images (MDA/2014/002) (88Kb)

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