Medical Device Alert: Workstation software for computed tomography systems: Vitrea fX, Vitrea and Vitrea Enterprise Suite manufactured by Vital Images (MDA/2012/081)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2012/081 or 2012/009/006/081/009

Technical aspects
David Grainger or Gica Leclerc
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ
Tel: 020 3080 7199 or 6610
Fax: 020 8754 3965
Email: david.grainger@mhra.gsi.gov.uk or gica.leclerc@mhra.gsi.gov.uk

Clinical aspects
Nicola Lennard
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ
Tel: 020 3080 7126
Fax: 020 8754 3965
Email: nicola.lennard@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 (external link)

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 (external link)
Further information about SABS can be found on the SABS website (external link)

Enquiries and adverse incident reports in Scotland should be addressed to:

Incident Reporting and Investigation Centre
Health Facilities Scotland
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

Health Facilities Scotland Incident Reporting and Investigation Centre (IRIC) (external link)

Enquiries in Wales should be addressed to:

Improving Patient Safety Team
Medical Directorate
Welsh Government
Cathays Park
Cardiff CF10 3NQ

Tel: 029 2082 3922
Email: Haz-Aic@wales.gsi.gov.uk

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.

• Identify affected systems.
• Contact the manufacturer to arrange installation of the software update.
• Follow the workarounds described in the manufacturer’s Field Safety Notice (136Kb) regarding selection of manual method and interpolate functions.
• Assess the need to review previous patients' treatment plans.

Action by

Radiologists, cardiologists, cardiac and vascular surgeons.

This MDA has been sent to:

• NHS trusts in England (chief executives)
• Care Quality Commission (CQC) (headquarters) for information
• HSC trusts in Northern Ireland (chief executives)
• NHS boards in Scotland (equipment coordinators)
• Local authorities in Scotland (equipment coordinators)
• NHS boards and trusts in Wales (chief executives)

Onward distribution

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

• Cardiologists
• Cardiology, directors of
• Cardiothoracic surgeons
• Cardiothoracic surgery directors
• Clinical governance leads
• Coronary care departments
• Director of nursing
• Medical directors
• Medical physics departments
• Radiation & medical oncology departments
• Radiographer superintendents
• Radiographers
• Radiologists
• Radiology directors
• Risk managers
• Vascular surgeons

Independent distribution

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

• Hospitals in the independent sector
• Independent treatment centres
• Private medical practitioners

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
Vital Images Customer Support Europe
Tel: +31 70 413 5801
Email: eusupport@vitalimages.com

UK Distributor
Paul Hughes
Sales Manager
Vital Images UK
50 Broadway
London SW1H 0RG
Tel:    07960 685 267
Email:    phughes@vitalimages.com

Manufacturer USA
Parthiv Shah
Vital Images, Inc.
5850 Opus Parkway Suite 300
Minnetonka
MN 55343-4414  USA
Tel:    +1 952 487 9514 or +1 612 816 2985
Fax:   +1 952 487 9510
Email:    pshah@vitalimages.com

Vital Images Customer Support
USA
Tel:    +1 800 208 3005
Email:    support@vitalimages.com

UK Distributor
Paul Hughes
Sales Manager
Vital Images UK
50 Broadway
London SW1H 0RG
Tel:    07960 685 267
Email:    phughes@vitalimages.com

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